QA Compliance Resume Samples
4.9
(96 votes) for
QA Compliance Resume Samples
The Guide To Resume Tailoring
Guide the recruiter to the conclusion that you are the best candidate for the qa compliance job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.
Craft your perfect resume by picking job responsibilities written by professional recruiters
Pick from the thousands of curated job responsibilities used by the leading companies
Tailor your resume & cover letter with wording that best fits for each job you apply
Resume Builder
Create a Resume in Minutes with Professional Resume Templates
CHOOSE THE BEST TEMPLATE
- Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS
- Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES
- Instantly download in PDF format or share a custom link.
DL
D Lindgren
Darrin
Lindgren
2494 Deja Shoals
Houston
TX
+1 (555) 225 5214
2494 Deja Shoals
Houston
TX
Phone
p
+1 (555) 225 5214
Experience
Experience
New York, NY
QA / Compliance Associates
New York, NY
Moore-Bartell
New York, NY
QA / Compliance Associates
- Provide the corresponding reporting as scheduled to Operational Management, Training Manager and Compliance Leader
- Provide feedback and coaching to the billing representatives and managers based on the defects identified
- May lead process improvement initiatives
- Provide assistance to Internal Control, Xerox Internal Audit (XIA), and other Xerox external Auditors Price Waterhouse Coopers (PwC) and Ernst & Young (E&Y)
- May act as a lead to more junior technical or administrative support personnel. Incumbents independently perform a wide range of complex duties under general guidance from supervisors
- Maintain all inspection results, work papers and agreements, per Xerox retention schedule
- Track results and select the corresponding inspection samples of Base Business Billing transactions to ensure compliance to procedures, policy and to support SOX controls
Chicago, IL
QA Compliance Manager
Chicago, IL
Wehner, O'Connell and Klocko
Chicago, IL
QA Compliance Manager
- Develop, implement and continue to improve Audit Program Metrics
- Manage the QA Compliance Department, coaching and developing your team to ensure the highest quality service is delivered
- Partner with the Business Excellence Manager to deliver all QA projects related to driving process and systems improvements
- Management of the Clinical Phase Supplier Quality Management (SQM) Program
- Management of site internal GMP audit program, performs site internal GMP audits, and supports site GXP/QSR/REMS inspection readiness
- Management of Clinical Quality/Technical Agreements
- Manage the Review process and implement Annual Quality Plans across the site
present
Phoenix, AZ
QA Compliance Specialist
Phoenix, AZ
McDermott, Runolfsdottir and Kuvalis
present
Phoenix, AZ
QA Compliance Specialist
present
- Review of Batch Manufacturing Records, and Batch Disposition activities
- Assisting in Product related deviation Investigations
- Assisting in Laboratory Out of Specification Investigations
- Participate / facilitate Cross Functional Investigation Teams
- Provide training / workshops in relation to Deviation and CAPA Systems
- Tracking and trending of deviations and CAPAs
- Investigation and reporting on Customer Complaints and Material Returns
Education
Education
Bachelor’s Degree in Scientific Field
Bachelor’s Degree in Scientific Field
Arizona State University
Bachelor’s Degree in Scientific Field
Skills
Skills
- Excellent communication skills (ability to communicate and coordinate between multiple teams and a cross-disciplinary audience)
- Critical thinking and the ability to articulate verbally and written to all levels of management are essential
- Strong fluency in Microsoft console manufacture standards with 5+ years of experience working in a QA department in the video games industry
- Technical education or equivalent experience with working knowledge of common industry build and production tools
- Sound administrative and computer skills are necessary including MS Office Suite; SharePoint and Oracle knowledge are
- Able to work in a fast-paced, fluid episodic environment with minimal supervision
- 3+ years of experience within a QA department testing certification standards
- Ideal candidates will have some scripting or programming experience, especially in the area of unit tests and automated testing
- Familiarity 5S/lean manufacturing concepts
15 QA Compliance resume templates
Read our complete resume writing guides
1
QA Compliance & Systems Specialist Resume Examples & Samples
- Bachelor's degree in the field of Science or Engineering or other appropriate field of study
- Minimum of 3 years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry, including supplier management experience
- Biopharmaceutical experience a plus
- Strong knowledge of EU, FDA and cGMP regulations
- Supplier or contractor auditing experience preferred
- Experience in conducting investigations is required
- Excellent interpersonal effectiveness and written and verbal communication skills
2
QA Compliance Specialist Resume Examples & Samples
- Review of Batch Manufacturing Records, and Batch Disposition activities
- Assisting in Product related deviation Investigations
- Assisting in Laboratory Out of Specification Investigations
- Participate / facilitate Cross Functional Investigation Teams
- Provide training / workshops in relation to Deviation and CAPA Systems
- Tracking and trending of deviations and CAPAs
- Investigation and reporting on Customer Complaints and Material Returns
- Follow-up and verification of completion of Corrective and Preventive Actions
- Material status control
- Promoting Right First Time and Continuous Improvement culture by using analytical tools, introduction / updating of site systems and solutions
- Monitoring applicable Quality Systems, compiling metrics and reports on a regular basis
- Preparation and review of Vendor Approval documentation
- Preparation and review of Service Supplier documentation
- Training of new hires in relevant SOP and Quality System procedures
- Support / represent systems during regulatory audits, assisting and supporting cGMP audits
- Completion of in-house GMP Inspections and Internal Audits
- Producing and reviewing of documents (SOPs, training modules / materials) in compliance with site procedures and regulatory requirements
- Preparation and control of Annual Product Reviews
- BSc (minimum) in a Scientific Discipline is essential
- A minimum of 2 years working within QA in the pharmaceutical industry
- Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements
3
QA Compliance Specialist Resume Examples & Samples
- BSc in a Scientific Discipline
- A minimum of 2 years working within QA department ideally in the pharmaceutical industry
- Experience in API is desirable
4
Manager RD QA & Compliance Resume Examples & Samples
- Provide professional expertise and strong leadership in Good Clinical practice (GCP) and applicable regulations and guidances and
- Proactively identify compliance status and issues/risks (and escalate as required) in assigned clinical studies / or a program within the organization
- 15-20%
- 40-60%
- 10-15%
- 5-20%
- A minimum of 8 years of relevant pharmaceutical experience
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP QA and/or GCP Compliance
5
QA Compliance Officer Resume Examples & Samples
- Checking submitted test plans and test completion reports containing the correct level of details so that it would be clear to an auditor what had been tested and how
- Monitoring the level of completed testing in line with UBS testing standards
- Creating and maintaining reports in order to early identify where test teams might be non-compliant
- Acting as a testing standard SME and point of contact for global test teams questions
- Producing on demand reports to illustrate compliance with different global regulations
- Performing sample based detailed analysis of the testing that has been done for specific releases and reports produced for QA managers
- Assisting auditors in collecting test evidence from global test teams
6
Teammate, QA Compliance Resume Examples & Samples
- Strong Computer Skills (Excel)
- Knowledge of WMS
- Forklift experience or the desire to be trained on Forklift
- Must be 18 years old
- Must have High School Diploma/GED
- Must have at least 1 year of recent continuous employment
7
Senior Manager of QA & Compliance Resume Examples & Samples
- 7-10 years experience in garment manufacturing with expertise in the areas of product quality specification, product technical compliance, and QA/QC production
- Quality program, quality engineering, testing and equivalent technical experience in finished goods consumer product/apparel manufacturing/production, product quality specification and regulatory compliance is required
- Intimate knowledge of fabric quality
- Technical background with knowledge and conversant in garment and wash process
- Experience working with overseas factories
- Knowledgeable in on the relevant aspects of law
- Ability to communicate across multiple cultural and experience levels
- Travel Required
8
Watson Health QA Compliance Program Specialist Resume Examples & Samples
- Knowledge and experience in compliance laws and regulations, access, release of information, and release control technologies
- Demonstrated organization, facilitation, communication, technical writing and presentation skills
- Maintains current knowledge of applicable federal and state healthcare regulations, laws and accreditation standards, and monitors advancements in compliance technologies to ensure organizational adaptation and compliance
- At least 5 years of work experience in a healthcare device or life sciences pharmaceutical company
- At least 2 years of work experience in a software development company
- 7 years of work experience in a healthcare device or life sciences pharmaceutical company
- 3 years of work experience in a software development company in the Cloud and Mobile platform industry segment
9
Data Coordinator / Radiology QA / Compliance Resume Examples & Samples
- Creates and maintains a quality improvement program that will measure those systems, processes and jobs that most directly and tangibly affect patient outcomes
- Writes quality improvement work plans and program descriptions and submits to management for approval
- Develops the analytic and measurement strategy undertaken by QA, PI and other projects including development of key metrics, identification of data sources, collection of baseline data and outcome measurements
- Reports analysis to Hospital QA, Directors and other departments
- Analyzes trended data used in the QA process and identifies opportunities to improve delivery of Radiology services
- Develops process improvement initiative as dictated by management, CHS goals and initiatives and/or the QA program
- Facilitates QA/ PI teams as needed to insure linkage with CHS and Radiology's mission, vision and corporate strategies
- Performs initial and periodic information risk assessments with RIS and digital environment. Documents all audit outcomes
- Obtains medications, radiopharmaceuticals, or contrast materials directed for administration by a licensed practitioner, authorized/certified technologist or registered nurse
10
Head of Technology QA & Compliance Resume Examples & Samples
- 30%: Creation and Execution of CSV Plan
- 20%: Management
- Developing People: Help employees continually grow through challenging opportunities so they can realize their potential
- Fostering a Brave Culture: Show employees what Brave looks like by being a role model. Create the environment in which people are able to be Brave and a culture where any risks are always in compliance with applicable laws and regulations
- 10%: R&D QA & Compliance Leadership
- Bachelor’s degree in a life science or equivalent required; Masters Degree in management or scientific discipline a plus
11
Senior IT QA Compliance Manager Resume Examples & Samples
- 7+ years of IT experience with a Bachelors
- 5+ years of IT Experience with a Masters
- 5+ years of experience providing work direction and leadership to people and teams
- Experience leading QA efforts in a regulated environment
- 5+ years in working with quality, manufacturing or clinical IT processes
- Solid understanding of the quality regulations and auditing techniques required for the medical device industry
- Ability to create and deliver presentations up to the Executive Committee level
- Excellent communication skills (oral, business writing, presentations and listening)
- High energy and motivation with an ability to quickly adapt to change
- Front room / back room audit experience
- Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs including leading sessions with internal auditors and meeting with external regulatory agencies
- CobiT, ITIL, and PMI certifications helpful
- The employee is also required to interact with a computer or mobile device and communicate with peers, co-workers and management
- Must be able to travel independently to various Medtronic buildings / sites
12
QA Compliance Specialist Resume Examples & Samples
- Develop an effective compliance framework for the Supply Chain department through the development and implementation of appropriate compliance related policies and procedures
- Act as a liaison between the Supply Chain Department and onsite quality and regulatory groups to define and address all issues of non-compliance
- Facilitate all reviews and revisions of all Supply Chain Department related SOP's, plans and policies for each group within the Department
- Provide support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as CC's, NOE's, and DNF's, impact statements and corrective action plans
- Participate in investigations and root cause analysis for all Supply Chain Department issues of non-compliance
- Provide tracking and trending for all supply chain and materials management compliance activities i.e NOEs, EOE’s, CAPA’s
- Provide periodic review of Supply Chain Department documentation and records such as logbooks, receiving reports and Dispensing MR’s to assess for compliance with established quality standards, policies and procedures
- Collaborate with other functions and Rensselaer site to support compliance requirements
- Drive proactive compliance environment in the Supply Chain and Materials Management team through completion of self audits, knowledge transfer and education of compliance related items
- Participate in and obtain results of all Supply Chain Department quality and regulatory audits
- Coordinate training for Supply Chain personnel on regulatory and quality topics such as proper documentation procedures and the use of QUMAS
- Follow current good manufacturing practices (cGMPs)
- BS/BA in engineering or scientific related field with 5+ years of related professional experience in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of educational requirement
- Understanding of warehouse operations, temperature control and cold chain logistics in a cGMP environment desirable
- Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization
- Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint)
13
Program QA & Compliance Lead Resume Examples & Samples
- 50%: Compliance Support
- 25%: Create and Execute Program Compliance and Audit Plan
- 15%: Regulatory Agency Inspection Support
- Bachelor’s degree required with a life science focus preferred; Masters Degree in management or scientific discipline a plus
- A minimum of 10 years of relevant pharmaceutical experience
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP QA and/or GCP Compliance with 3 years of management experience
14
Technology QA & Compliance Leader Resume Examples & Samples
- Under the direction of the Head of R&D Technology QA & Compliance, this position is responsible for providing support in the management and QA oversight of Computerized Systems Validation activities related to Shire systems utilized by R&D
- Principal responsibilities include
- Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/ GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners
- Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in R&D
- Fosters relationships with Global R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs
- Represent R&D in interactions with various Shire groups outside of R&D (TechOps, IT, etc) to evaluate best practices for continuous improvement of Computer System Validation compliance across Shire
- Coordinates and collaborates with the internal QA & C CoEs to provide consistency across QA&C process as well as programs and reporting
- Represent R&D in ensuring the enterprise applications are designed, validated and maintained in a manner which supports the use of these applications in compliance with Global R&D regulations
- Serve as a Subject Matter Expert (SME) in Computer System Validation requirements for systems used by Shire’s global R&D Organization
- Manage the development, implementation and maintenance of the Quality Assurance programs and activities in support of R&D computerized systems used to support regulatory applications environment to ensure compliance with Domestic and International requirements
- Provide guidance to R&D Sr Management in preparation for regulatory inspections
- Serve as key company representative and SME during any global R&D agency inspection
- Develop positive working relationships with global R&D stakeholders and ensure that compliance objectives are met
- Develop and/or review all responses to regulatory agency inspections and corrective action commitments related to CSV requirements, ensure that timely responses are generated
- Ensure Quality Assurance oversight and involvement in Computer Validation Projects supporting R&D activities
- Manage/perform internal and external audits to evaluate computerized system vendors, external hosting providers, and internal validation project deliverables
- Bachelor’s degree in a life science or computer science required; Masters Degree in management or scientific discipline a plus
- Ideal candidate will have broad experience in computer system life cycle development;/computer system validation in R&D
- Idea candidate will have demonstrated experience leading cross functional teams without authority, advising on compliance related matters, and influencing Sr Leaders
15
Supervisor, QA Compliance Resume Examples & Samples
- Provide daily oversight and guidance. Develop group goals and assist in implementing these goals and manage performance
- Ensure that key quality systems are developed and implemented in accordance with company quality policies and regulatory agencies
- Responsible for timely support and ensuring GMP compliance for deviations, CAPA, change controls, audits, complaints, metrics, batch reviews and product reviews
- Experience in aseptic processing and powder filling operations desired
- Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations
- Project management experience including scheduling, tracking and auditing
- Minimum of 5-8 years’ experience in a Quality Assurance role in the pharmaceutical industry
16
Manager Batch Record Review im Bereich QA Compliance Resume Examples & Samples
- Leading the QA Operations Batch Record Review department
- Management of the employees
- Control of the timely and efficient batch record review, finished drug product testing and preparation of QP release documentation, while keeping the throughput times
- Ensuring timely creation of certificates
- Capacity planning
- Ensuring GMP compliance of the department
- Collection of key performance indicators (KPI), such as Right First Time and Test and Approve
- Ensuring the continuous process optimization of the department
- Development, review and approval of quality systems and relevant documents in close co-ordination with colleagues from other departments at the global and local level
- Participation in the preparation and implementation of public inspections and internal audits
- Assessment of deviations during the manufacturing / testing as well as non-medical complaints
- GMP-QA representation in interdisciplinary product development teams (e.g. CMC teams, supply chain management) or product transfer as NPI coordinator
- Supervision of projects as well as capacity and budget planning within the QA
- Several years of professional experience in the pharmaceutical industry in quality assurance, manufacturing or testing of drug products
- Knowledge of SAP QM and TLIMS Sample Manager
- Knowledge in Lean Six Sigma, project management
- Experience in batch record review is an advantage
- Negotiable English and very good computer skills required
17
QA Compliance Specialist Resume Examples & Samples
- Educated to third level in science based discipline. Degree level preferable
- Minimum 3 years pharmaceutical experience in a regulated environment would be preferable. Experience in pharmaceutical environment a significant advantage
- Compliance activities: Supplier Qualification, Change Control, Internal/External Auditing, Managing suppliers, raw materials ect
18
QA Compliance Specialist Resume Examples & Samples
- Implement and maintain processes and procedures for a closed-loop CAPA system to ensure quality system and product performance are monitored, trended and appropriate actions are taken in a timely manner
- Assess and analyze the QMS for efficient compliance to regulations on a periodic basis and provide results and recommended strategies
- Support internal functional partners and ensure process owners are trained and educated in the areas of the quality system regulations as applicable to their area(s)
- Conduct periodic audits and plant walk-throughs to ensure compliance to FDA’S QSR regulations
- Review and approve validation plans and reports
- Ensure validation activities are in compliance with ISO9001, 21 CFR 820 and 21 CFR part 11
- Develop and perform software validation protocols in compliance with regulations and write validation reports
- Effectively communicate with other departments on quality and compliance issues
- Participate in vendor, customer, registrar and regulatory audits
- Participate in and lead quality and process improvement projects
- Prepare, revise and implement relevant SOPs related to the QMS
- Review and approve product and process deviations
- Develop and conduct annual QMS and regulatory training
- Properly interpret and apply regulatory requirements
- Review batch documentation and perform product release for regulated products
- Conduct supplier audits
- Perform all job duties in a safe manner and obeys all safety policies and procedures
- Perform all job duties consistent with the Code of Ethics and the 4-I values
19
QA / Compliance Reps Resume Examples & Samples
- Review and propose process improvement opportunities
- Provide the corresponding reporting as scheduled to Operational Management, Training Manager and Compliance Leader
- Share inspection findings, clear results and reach consensus and confirm resolution of defects with Operational Managements
- Provide feedback and coaching to the billing representatives and managers based on the defects identified
- Identify and create new inspections or controls to improve organizational performance and objective achievement
- Support procedure, policy and process reviews and related communications
- Interface with various staff and management levels to facilitate communications, coordinate efforts and to assist in the resolution of issues, gaps, and requirements
- Participate in gap / defect closure and reporting activities
- Provide support and share knowledge with other Xerox employees
- Excellent written & verbal communication skills – preferred
- The Below Will Be Completed By Xerox Services Based Off Data Received From the Xerox Hiring Manager**
20
QA Compliance Intern Resume Examples & Samples
- Supports the deviations and CAPA process by handling deviations and CAPA andexecuting investigations within assigned areas of responsibility, under guidance from QA Compliance team members
- Supports the change control process. Performs action plan evaluation and coordinateschange control progress within assigned areas of responsibility, under guidance from QA Compliance team members
- Supports the product quality complaints process by handling complaints and executinginvestigations as assigned, under guidance from QA Compliance team members
- As a member of the Quality Operations team, position holder will be working closely with the QA Compliance team members to identify and handle product /process quality and cGMP compliance related issues/improvements
- The QA Compliance Intern can be assigned otherbased on required business needs and support to stakeholders of the Quality Operations department
- Product /process quality and cGMP compliance related issues/improvement *Li-Ex
- Minimum: on going BSc in Science, Engineering or Technical discipline
- Knowledge of international GxP regulations, 21CFR11, and good documentation practices
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems
- Ability to focus attention to detail
- Ability to work independently and effectively in a team
- Knowledge of most common office software (Microsoft Office) especially in Excel
- Good communication skills (written and verbal) in French
21
QA Compliance Manager Resume Examples & Samples
- Management of the Clinical Phase Supplier Quality Management (SQM) Program
- Performs vendor audits, (Contracted Manufacturing, Packaging/Labeling, and Laboratory Organizations, Active Pharmaceutical Ingredient (API) vendors, excipient vendors, raw material vendors, device component vendors, etc.)
- Management and maintenance of the Clinical Phase GMP Approved Supplier List (ASL) and Audit Schedule
- Active member of the Global SQM Team and will coordinate with Alkermes Commercial Sites to support a Global SQM Program and integrated Audit Schedule
- Management of Clinical Quality/Technical Agreements
- Management of site internal GMP audit program, performs site internal GMP audits, and supports site GXP/QSR/REMS inspection readiness
- Auditor training with a focus in data integrity auditing; qualifying auditors and SMEs for external auditing
- Troubleshoots issues, develops and implements effective risk mitigation strategies as required
- 10-15 years of experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
- Certified Quality Auditor is considered a plus
- Working knowledge of US and European Drug Product GMP requirements and associated guidelines including working knowledge of ICH Q7 API GMP Guide
- Experience with Quality System Regulation (QSR), GCP, and/or GLP is considered a plus
- Experience in administration and development of quality systems
- Experience in product development and expectations for early phase clinical trials
- Strong decision maker, applies job related skills and understanding of policies and standards in completing tasks
- Expert knowledge on regulatory requirements and industry expectations for Supplier Quality Management
- Strong focus on continuous improvement, customer service and collaboration
- Ability to be influential across levels of the organization
22
QA / Compliance Director Resume Examples & Samples
- Lead and coordinate PV compliance risk assessments, including for purposes of providing input into the annual R&D audit program
- Provide expert compliance advice on PV strategies, programs, processes, initiatives and activities (including labeling) to help manage and mitigate risk
- Manage, facilitate and support regulatory agency inspections
- Ensure compliance oversight for the implementation, management, and monitoring of operational activities supporting Amgen’s Risk Evaluation and Mitigation Strategy (REMS) programs
- Lead and develop staff to ensure proactive and timely identification and effective management of PV compliance issues
- Facilitate timely and appropriate remediation and response to PV findings from internal audits and regulatory agency inspections
- Report and escalate significant compliance issues to R&D Compliance management and senior PV stakeholders
- Serve as PV Compliance representative on senior compliance/ quality oversight bodies
- Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure related to pharmacovigilance
- Develop and deliver periodic PV compliance reports, including relevant metrics, to key stakeholders and management
- Assess PV impact of changes in new regulations and the external environment and advise stakeholders accordingly
- 10-15% travel, depending on location
23
QA / Compliance Associates Resume Examples & Samples
- Reconciles general ledger accounts, prepares balance sheet reconciliation and clears exception items
- Posts ledger and general journal entries
- Track results and select the corresponding inspection samples of Base Business Billing transactions to ensure compliance to procedures, policy and to support SOX controls
- Ensure accuracy of billing transactions to provide invoice quality by monitoring the various inputs in to the billing process, highlighting to both manager and representative any defects and provide recommendations / requirements to correct the defect
- Perform detailed inspection on current billing processes to ensure compliance to policies, procedures and to support of SOX controls
- Analyze inspection results to prepare and make recommendations through data driven findings
- Ability to assess findings and make decisions
- Ensure actions correcting the defects are completed on a timely basis
- Document all changes to the inspection process, as appropriate
- Maintain all inspection results, work papers and agreements, per Xerox retention schedule
- Provide assistance to Internal Control, Xerox Internal Audit (XIA), and other Xerox external Auditors Price Waterhouse Coopers (PwC) and Ernst & Young (E&Y)
- Strong problem solving and communications skills
- Ability to translate business requirements into functional specifications
- Ability to interact effectively with associate and management levels – preferred
- Presentation skills – preferred
- Proficient with Microsoft Office (Outlook, Word, Excel and PowerPoint) – preferred
24
Global QA & Compliance Program Lead Resume Examples & Samples
- Bachelor’s degree, MBA a plus
- English language fluency, German language is a plus
- Eight to twelve years of experience with QA systems including SOP programs, training and change management
- Preferred experience with setting site and global GxP standards and procedures
- Track record of project compliance leadership and/or participation
- Global business environment (vendor) experience preferred
- A seasoned credible Leader respected within the organization to lead substantial change within CSL
- Preferred experience with project management and change management
25
Manager / Senior Manager GCP, QA & Compliance Resume Examples & Samples
- Oversee and monitor the Clinical Development areas compliance to the vendor oversight related procedures which include qualification, management, escalation, and reporting of quality and compliance related issues. Ensures all applicable deliverables and documentations are created, retained, and archived per Ionis procedural, contractual, and applicable regulatory requirements
- Understand the business priorities and requirements from various Clinical Development Functional Heads or designee(s) and Clinical Development areas processes and systems as the criteria in developing a risk based and holistic vendor oversight strategy
- In collaboration with the Functional Area Head or designee(s), develop relationships with vendors to enable mutual understanding of expectations, deliverables, and issue resolution
- Perform risk assessment of current and future contracted services as inputs to the vendor oversight strategy
- Implement a risk based vendor oversight strategy for key and preferred vendors including functional service providers
- Develop and manage vendor governance with defined roles and responsibilities, communication pathway, and deliverables
- Lead and facilitate vendor oversight team meetings which include internal and external stakeholders with appropriate representation from various areas as part of the holistic approach
- Work with the Development areas representative to resolve and mitigate vendor performance issues. Perform lesson’s learned as part of the continuous process improvement activities
- Work with internal and external stakeholders to identify key performance indicators (KPIs) in developing Ionis vendor metrics. Ensure periodic evaluation of these metrics to assess trends related to quality and compliance of vendor’s contracted deliverables and issues. These metrics will be reported and communicated internally
- Develop tools to aid the Clinical Development areas representative in proactively managing their respective contracted vendors
- Create and maintain a vendor database to track which franchise/study and associated services are contracted to key and preferred vendors
- Conduct activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines, as well as all policies and procedures
- Stay current with new or revised regulations, regulatory intelligence, and best practices
- Other activities (e.g., audit, inspection readiness support), special projects, and assignment may be given as required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting will vary depending on project assignments, current development projects, and the requirements within the organization as a whole
26
QA Compliance Manager Resume Examples & Samples
- Develop, implement and continue to improve Audit Program Metrics
- Implement and maintain both internal and external audit program
- Manage the Approved vendor program
27
QA Compliance Auditor Resume Examples & Samples
- Perform Internal company audits, CAPA approval and tracking to ensure implementation
- Support the scheduling, execution and CAPA resolution of internal and third party quality system compliance audits
- Generate audit reports and conduct follow-up evaluations on corrective actions which address non-compliance audit observations
- Responsible for the inspection readiness status of the site for external audits
- Determine completeness of Regulatory Inspection Documentation
- Determine Inspection Strategies, responsible observation owners and adequate responses are written and put in place
- Act as advisor, facilitator and team member to QA and Barnard Castle site teams regarding regulatory compliance and quality systems for all aspects of manufacturing, filling, finishing, packaging and testing of biological products
- Be able to lead, manage and maintain the quality risk management process of the site
- Coordinate and investigate quality alerts for the Barnard Castle site and assure adequate
- Communicate audit related issues to internal stakeholders through appropriate escalation processes to ensure stakeholders understand technical, regulatory and quality risks
- Develop and publish linked metrics for Compliance activities to QA Site Management and Quality Council
- Determine Good Manufacturing Practice (GMP) compliance status of manufacturing, QA and support system operations
- Perform evaluation to ensure site compliance with regulatory and internal standards for all GMP activities at Barnard Castle
- Facilitate quality compliance process improvement within other departments, through the use of training, coaching and team participation
- Support continuous improvement activity, gathering facts & data, and recommend solutions and check effectiveness once actioned
- Ideally possess a degree in a scientific or technical discipline (e.g. Chemistry, Pharmacy, Microbiology or Engineering). Demonstrable experience in a similar role will also be considered
- A proven track record of achievement within a QA Compliance orientated role in a high pressure, fast moving manufacturing environment
- Experience of scheduling and conducting site audits to identify, manage, correct and reduce significant risks/non compliance
- Knowledge of regulatory and quality system requirements and possess the ability to build relationships, explain, influence and negotiate with internal stakeholders to comply with standards
- Exposure to continuous improvement projects e.g. GMP, WCM, Six Sigma etc
- Be comfortable with building and maintaining relationships, cross functionally, in a matrix environment in order to effectively negotiate and solve problems
- Possess attention to detail paired with the ability to organise, prioritise and deliver tasks/projects with a sense of urgency, looking to drive change, whilst ensuring a focus on internal and external customers
28
APL QA Compliance Specialist Resume Examples & Samples
- Responsible for generating and maintaining company Standard Operating Procedures (SOPs), and Supporting Documents in compliance with external regulatory/legislative requirements
- Responsible for coordinating the implementation of the Novartis Quality Manual and ensuring the ongoing site compliance
- Coordinating the annual site quality risk assessment, generate and follow up on resulting CAPAs
- Consolidate Annual Quality Plan according local business strategy and Corporate Quality
- Identify and implement compliance metrics
- Maintain an awareness of changes in regulatory guidance and Corporate policies regarding quality management
- Provide training to company associates on core quality system functions
- Conduct internal quality audits to demonstrate the level of compliance of the business unit and assist with external audits/inspections
- Provide support and guidance to ensure APL computers systems are and remain validated as per GxP requirements
- Provide reports on a monthly basis to management on the progress of outstanding local corrective and preventative actions
- Perform activities as APL Responsible Person (RP) in line with the Swiss Medicinal Products Licensing Ordinance, MPLO (AMBV)
- Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the associate has the necessary experience and/or training
- Knowledge in quality assurance or a related discipline
- Knowledge of regulatory requirements and guidelines for drugs and devices
- Familiarity with ISO 13485 and GxPs
- Database and reporting experience (MS Office Suite)
- Experience with Swissmedic trading requirements (a plus)
29
Research QA & Compliance Lead Resume Examples & Samples
- Responsible for supporting Head of Research Compliance to oversee the compliance function in support of all Research programs / projects in R&D
- Provides professional expertise, guidance and strong leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. CAP, CLIA) to proactively identify compliance issues/risks in all Nonclinical, analytical and Bioanalytical studies within the organization and its external partners (as applicable)
- Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in Research
- Fosters relationships with R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs
- Perform study/project specific and program/process audits in support of GLP activities (as applicable)
- Manage the development, implementation and maintenance of the Quality Assurance programs and activities in a regulated environment to ensure compliance with federal/state and country regulations (as applicable)
- Provide guidance to Research & Development Management in preparation for regulatory inspections
- Serve as key company representative during agency inspection, interface and host inspections, develop positive working relationships and ensure that compliance objectives are met
- Develop and/or review all responses to regulatory agency inspections and corrective action commitments, ensure that timely responses are generated
- Ensure Quality Assurance oversight and involvement in Computer Validation Projects supporting Research activities
- Bachelor’s degree (or equivalent combination of education and experience) in a life science required; Master’s Degree in management or scientific discipline a plus
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GLP auditing and at least 7 years of direct management experience
- Extensive knowledge and/or awareness of domestic and international GLP regulations
- Strong leadership skills, and ability to inspire colleagues
- Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems
- Strong judgment, project management and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Shire
- General management skills (e.g. budget management, performance management)
- Strong technical writing skills. Ability to write quality positions, audit reports and SOPs
- Strong attention to detail with the ability to articulate quality related risks and potential impact
- Strong knowledge of MS Word, Excel, PowerPoint & Outlook
- Good understanding of the drug development processes, nonclinical operations, regulatory affairs and GLP auditing
- A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project
- Supports a culture of innovation and a BRAVE culture, while recognizing the need for an appropriate culture of compliance
- Knowledge of regulatory guidelines in different geographic regions
- Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity
- Influences without authority, in a matrix environment
- Strong attention to detail and ability to analyze complex data
30
QA Compliance Level Resume Examples & Samples
- Preferred area of study: Scientific related field
- Entry/Early Career experience in a GMP environment of experience in GMP environment
- Direct exposure to Regulatory Inspections and Customer Audits
- Self motivated and results oriented, with superior written and verbal communicator at all levels, able to tolerate
31
QA-compliance / Jaws Resume Examples & Samples
- Study and analyze software requirements/specifications and create test scenarios/cases
- Good hands on knowledge of HTML, CSS, JavaScript, Usability and Front end
- Hands on experience with Accessibility testing tools like Jaws, NVDA, FAE etc
- Good knowledge of Section 508 and WCAG 2.0
- Solid background in both SDLC and business processes
- Leading QA activities for Accessibility and other UI related testing using automated testing tools
- Minimum 3 years of experience in UI application testing
- Manual Testing for System/Integration/Regression testing as per test plans
- Track bugs/issues and update defect status
- Prioritize work as per project schedule and quality goals
- Participate in walkthrough meetings and in production check-out tasks
- Take initiatives to enhance domain/technical knowledge
- Quality Assurance Engineering, Regression Testing, Defect Tracking, Test Execution , Test Planning Qualifications To be considered for this position, applicants need to meet the qualifications listed in this posting
- Total QA experience of 3+ Years
- Understanding of SDLC
- Work experience in Agile Lifecycle
- Work experience in Rally and ALM Tool
- Work experience in Selenium Automation preferred
- Basic SQL knowledge for database testing
- Knowledge of Healthcare
- Defect Reporting & Tracking -Should carry a positive attitude and a good team player
32
GMP QA Compliance Resume Examples & Samples
- Provide hands-on execution of Quality Systems and Compliance activities
- Schedule and coordinate GMP internal and external audits and develop appropriate corrective and preventive action plans
- Establishes standards for inter-company Quality Agreements, and drafts and negotiates agreements with contractors in collaboration with Array
- Assist with execution of corrective action Protocols for the Supplier Quality Assessment and Quality Assurance Agreements
- Assess the existing Supplier files for completeness and develop a prioritization and schedule for tasks to be completed. Commence hands on work according to the required tasks outstanding
- Contact Suppliers regarding elements pending for supplier files (surveys, audit responses, inspection history, etc.) to resolve outstanding documentation
- Manage updates to the Supplier file, by the review and uploading of relevant documentation received
- Assess the QAAs pending completion, develop a schedule for completion and follow up with Suppliers / Contractors for the review and completion of new QAAs
- Assist with monthly progress reports for Management regarding the compliance against the Supplier Quality Program and QAA compliance. Present status at routine Quality Management Meetings
- Escalate any critical findings or compliance roadblocks to the Quality Assurance and Senior Management team in routine review meetings or according to internal escalation procedures
- 10 years of experience in a GMP Quality position
- Ability to perform compliance tasks independently with minimal oversight
- Demonstrated ability to accomplish results and meet deadlines and commitments
- Strong organizational skills, ability to multitask in a dynamic, fast paced environment
- Strong collaboration and written/verbal communications skills
33
Analytical QA Compliance Manager Resume Examples & Samples
- Perform the QA review/approval of technical documentation, including, but not limited to
- BS/BA in a life science field
- Minimum of 8 years of experience in biologics development, preferably having a strong background in the analytical analysis of biopharmaceuticals from a development or QC perspective
- Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials
- Excellent communication, relationship management, negotiation and problem-solving skills
- Knowledgeable on the development, content and authoring of Standard Operating Procedures and other guidance documents
- Knowledge of program management tools and techniques is highly desirable
34
QA Compliance Specialist Resume Examples & Samples
- Independently manage the corporate FSQA SharePoint site, to include developing the site architecture, granting site permissions, and updating site structure in conjunction with corporate SharePoint team, seeking input from senior and plant leadership
- Complete new product set-up documents
- Assure FDA registration of all SunOpta manufacturing sites, including co-packers
- Initiate SunOpta facility product mock recalls; complete customer driven mock recalls for SunOpta co-packers; Develop training documents and train QA personnel on mock recall/traceability and Oracle extractions
- Lead and independently manage the relationships between SunOpta and various certification bodies certifications (organic, Kosher, gluten-free, non-GMO, etc.) and assists in the management and collection of documents for. Negotiate/discuss reduced costs of services, if possible
- Develop standard operating procedures and training guides relating to the SunOpta QMS
- Complete and send customer annual requirement documents as requested. Contacts customers with questions on their requests
- Upload customer compliance documents to ICIX, TraceOne, Aspirago, and other databases. Work directly with the customers and the system developers of these systems to resolve any issues
- Maintains and manages data integrity and robustness of supplier, co-packer facility, and customer data by keeping food safety information current and on file. Reviews all documents for food safety effectiveness and impact to SunOpta. Work closely with suppliers and facilities to assure all specifications are clear, accurate and in place for ingredients, packaging, and finished goods
- Drives improvement to streamline and implement effective data entry and information management processes within the food safety and team as well as the overall team. Trains the facility compliance personnel on data entry processes
- Generate reports necessary to communicate food safety information status to the QA Managers and/or upper management, including
- Prior QA experience in food manufacturing is a plus
- Incumbent must possess strong analytical and problem solving skills
- Critical thinking and the ability to articulate verbally and written to all levels of management are essential
- Incumbent must be comfortable with data maintenance activities
- Sound administrative and computer skills are necessary including MS Office Suite; SharePoint and Oracle knowledge are a plus
- Must be self-directed, assertive and possess the maturity commensurate with being an effective specialist
35
QA, Compliance & CSV Specialist Resume Examples & Samples
- Knowledge of GxP regulations (GMP, GCP, GLP) and 21 CFR Part 11 a plus
- GAMP5, CMMI, and Six Sigma experience a plus
- Validation of GxP applications and qualification of GxP infrastructure a plus
- Experience with supplier assessments and vendor management processes a plus
- Report development and advanced skills in Access and Excel a plus
36
QA Compliance Specialist Resume Examples & Samples
- Develop test plans to verify game, front-end, and online content adheres to strict standards on all supported platforms
- Serve as an in-house expert on console, mobile, and desktop platform requirements, working closely with core engineering teams and project managers to diagnose software and hardware issues and verify execution of solutions
- Along with the entire compliance group, develop documentation and process to handle emerging production, core and build engineering requirements as needed to ensure clean submissions to first party partners
- Set the highest standards for bug discovery, tracking, and detailed reproduction steps to discover critical issues and to guide additional support QA
- Strong fluency in Microsoft console manufacture standards with 5+ years of experience working in a QA department in the video games industry
- 3+ years of experience within a QA department testing certification standards
- Ideal candidates will also have experience with Sony, Nintendo, Apple, Amazon, Google, and/or Steam marketplace requirements
- Excellent communication skills (ability to communicate and coordinate between multiple teams and a cross-disciplinary audience)
- Able to work in a fast-paced, fluid episodic environment with minimal supervision
- Technical education or equivalent experience with working knowledge of common industry build and production tools
- Ideal candidates will have some scripting or programming experience, especially in the area of unit tests and automated testing
37
QA Compliance Coordinator Resume Examples & Samples
- Bachelors degree in Food Science, Nutrition or related field required. Comparable work experience applies
- Minimum 2 years related experience in a food manufacturing environment
- Experience with implementation of corrective action programs a plus
- Knowledge in nutrition and food manufacturing regulatory requirements
- Knowledge of Genesis and SharePoint a plus
- Process Improvement, Analyzing Information, Strategic Planning, Verbal Communication, Emphasizing Excellence, Attention to Detail, Thoroughness, Dealing with Complexity, Ability to Multi-task
- Comprehensive knowledge of the FDA, USDA, CA Department of Health Services and other regulatory agencies
- Knowledge of FSMA, GFSI, HACCP
- Ability to relate well with and influence others
- Demonstrated computer and information technology skills
- Capable of managing multiple projects and prioritizing tasks
- Teamwork orientation
38
Senior Manager, IT QA & Compliance Resume Examples & Samples
- Supports all aspects of Computer System Validation and global IT activities for the systems that support cGxP processes
- Partner with IT and Business teams in the development, implementation, project management, release, periodic review and maintenance of new and/or updated IT systems
- Create and Revise existing Risk Management tools as part of a compliant Computer System and Automated Validation approach
- Support the department’s vision, propose plan(s) and manage project deliverables to prepare the organization to support the growing Computer System Validation needs of the business, including enhancement and optimization of Computer System Validation program
- Establish effective communication and collaborative relationships with Division business units, global sites and key stakeholders
- Provide subject matter expertise during regulatory and customer inspections of business sites
- Participate in the establishment of QA and Validation strategies, needs/requirements and associated plans of existing and new computer systems
- Maintain current knowledge of industry standards and regulatory requirements
- 10+ years’ experience in a cGxP-regulated environment, with exhibited knowledge and proficiency of system validation and quality activities
- 5+ years experience in a management or supervisory position, with direct experience overseeing Validation / Quality Assurance activities
- Demonstrated leadership, technical, communication, management, problem solving, risk management and project management skills
- Organizational and management skills to handle multiple global functional groups, with ability to effectively delegate work within a matrix environment
- Demonstrated ability to organize and enhance the maturity level of the IT and IT / QA functions through strategic plans and mentoring of IT and QA staff
- Ability to speak, present data and defend approaches in front of an audience and/or inspectors
- Experience in participating in regulatory inspections, presenting/defending divisional functions in audits or regulatory inspections
- Ability to comprehend technical information related to computer system development, life cycle maintenance, computer validation and regulatory requirements
- Working understanding and familiarity with FDA, European and Asia Pacific regulatory requirements, guidelines and recommendations for computer systems
- Robust problem-solving skills and attention to detail
- Multi-cultural exposure and understanding; global thinker
- Superior leadership skills including experience managing within a matrix environment
- Ability to collaborate at all levels across the organization
- Degree in computer systems, science or engineering. Advanced Degree is desirable
- Detailed knowledge of Computer System Validation, IT Quality Assurance, Software Development Life Cycle requirements and Regulatory Affairs compliance
- Experience participating in global IT Quality and Computer System Validation initiatives
39
QA & Compliance Supervisor Resume Examples & Samples
- Know and understand federal, state, and local food industry regulations and company policies as applicable to operations of facility (CFR, GMPs, SSOPs, HACCP, SQF, Organic etc.)
- Implement and maintain Quality Systems to ensure manufactured products meet all specifications
- Ensure all plant personnel are operating in compliance with plant and corporate procedures for Food Safety, Quality, and Safety
- Ensure that plant is operating in compliance with all customer, FDA and government regulations and SQF Certification requirements
- Coordinate and conduct facility audits, accompany investigators, and ensure corrective actions are tracked and follow-up reports are completed. This includes physical inspection of equipment, buildings, and facility grounds for internal, regulatory, or customer audits
- Assist production and operations management with development and implementation of corrective actions and appropriate documentation in response to audit and inspection findings
- Review laboratory and production documents daily to assess the quality of products, determine that products meet customer specifications, and approve products for release to customers
- Manage product "Hold and Release" programs for finished products and incoming goods
- Develop policies and procedures as needed and provide training to employees. Coordinate procedure management system for issuance, distribution, compliance, and review
- Develop, organize, and administer training for plant employees on HACCP, GMP's, SQF, and related food safety topics
- Convey company, facility, and department goals to employees. Track and report on plant quality Key Performance Indicators
- Participate on Quality and Operations teams
- Attend seminars to develop skills needed to improve job performance
- Act as coordinator for the HACCP program, facilitate committee meetings, and review HACCP documentation daily
- Develop, implement, and maintain the Food Defense plan in compliance with DFA and customer requirements
- Directly supervise laboratory technicians, schedule hourly shifts, and provide training and performance feedback
- Set up, calibrate, and troubleshoot laboratory equipment. Arrange for repairs as needed
- Develop, implement, and maintain a systematic method of auditing analytical results (split sample testing program)
- Conduct physical and organoleptic evaluations of products and ingredients
- Direct the testing and analysis of routine and special products, trials, etc., and provide effective reports to involved parties (management, vendors, customers, etc.)
- Coordinate with customers for new item setup, product specifications, labeling requirements, and complaint resolution
- Maintain customer documents and specifications, ensuring up-to-date information is provided to production
- Coordinate shipping of samples to customer(s) as needed
- Coordinate Pest Control program for facility
- Conduct investigations into incidents, quality issues, and complaints. Document findings, perform trend analysis, and communicate to employees and customers as appropriate
- Attend required training, including but not limited to, GMP's, HAACP, SQF, Safety, etc
- Proactively identify opportunities for continuous improvement to include Lean, Kaizen, 5S and Leader Standard Work
- BA/BS Science or Biological Science, Food Science, or related field
- 5 years of supervisory experience in dairy food lab environment
- Certified Industry Analyst Certification for PMO Appendix-N testing of Drug Residue in Milk
- SQF Practitioner Certification
- Ability to interact in a positive way with all personnel within Dairy Farmers of America and with our customers
40
QA Compliance Manager Resume Examples & Samples
- You will have QP staus or be in the process for achieving it; in addition to having a relevant degree in science and/or quality assurance
- 5 years + experience in a similiar quality environment in the pharma field
- 2 + years experience in auditing
- People management experience is preferred
41
Oxo-QA Compliance Manager Resume Examples & Samples
- Product test plan creation, validation and communication (internally/externally)
- Research of applicable standards & regulations that apply to multiple categories of products (food contact/storage items; juvenile –feeding, high chairs, strollers)
- Communicate results to internal/external stakeholders
- Test report logging into compliance database, reconciliation against prior test results of same/similar materials
- Anticipate lab testing needs (formulate budget)
- Review BOMs and test reports for errors/inconsistencies
- Store and sort document queue prior to their addition to product compliance database
- Analyze context of how existing test data may be applicable to other similarly constructed products
- Research answers to compliance questions that arise from various Product Development Teams
- Assist Sales Team with generation of necessary product compliance documentation by perusing product database for applicable products/test results
- Keep internal/external stakeholders apprised of upcoming regulatory changes
- Sort through product database for relevant items according to set testing schedule
- Ensure that legacy products remain compliant to evolving market changes
- Generate and organize necessary documentation to begin testing of these products
- Provide necessary parties with compliance certificates outlining product conformity to the specific markets that we sell
- Bachelor’s degree in Engineering or Materials Science OR minimum 3-5 years equivalent field work experience
- Competence reading scientific documentation containing legalistic language
- Strong attention to detail and ability to communicate to others
- Experience working with Chinese vendors and third party laboratories preferred
- Experience with database management systems (collecting, analyzing, and summarizing/parsing large groups of data for deliverable metrics.)
- Microsoft Office Suit (Excel, Outlook, Access, etc.)
- Ability to read technical bulletins; market compliance standards and laboratory test reports; research of industry regulatory bulletins & standards
42
QA Compliance Specialist Resume Examples & Samples
- Ensure compliance with all relevant laws and regulations as well as JM procedures, policies, and SOPs. The incumbent has first line responsibility for assuring that on a day-to-day basis, established procedures are followed by production, commercial and testing personnel
- BS in Chemistry or closely related science
- With a3-33+ years in QA/QC or API Production in an FDA/DEA regulated environment required
- Strong technical and interpersonal skills
- 23 June 2017
43
QA Compliance Expert Resume Examples & Samples
- Represents the Head QA Compliance Qualification & Validation in case of absence
- Represents QA Compliance Qualification & Validation in relevant aspects e.g. in dedicated projects and commercial manufacturing
- Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers, Computer System Validations and Filter Validations) including associated Risk Assessments and Deviations
- Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
- Review and approve other documents within the scope of the department (e.g. post control reports, shipping verification, Leachable and Extractable Reports
- Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
- Maintain relevant SOP’s, support for GMP training
- Support/Lead Self Inspectations (as Lead auditor or Co-Auditor)
- Support Inspectations by Health Authorities, customers etc
- Initiate and implement quality improvement projects
- Train and onboard new members of the team
- As CCEx QA gate approver in Agile PLM system or Change Control QA in Trackwise AQWA system assess all changes for their QA relevance. As a CCEx Change Phase Manager in Agile PLM or Site Change Coordinator in Trackwise AQWA
44
QA Compliance Officer AVP Resume Examples & Samples
- Delivering the annual Level 2 Controls testing programme
- Performance of pre-closure testing over Regulatory and Audit findings prior to their submission
- Assist the Regional QA Manager with the co-ordination of the annual QA programme of work
- Work with the Regional QA Manager to understand the prioritization of the programme globally
- Perform testing of the key controls operated by Compliance and report any issues / gaps to Senior Management
- An in depth understanding of the regulatory landscape within the global financial services industry and practical experience of working in a regulatory environment (Compliance, Risk, Audit etc.)
- The jobholder must be analytical, proactive and have a structured and organised approach, which demonstrates a high level of attention to detail to ensures that high quality deliverables are produced
- A positive and flexible approach is required to operate in DB’s constantly changing environment
- Excellent oral and written communication skills proven through experience of MI reports and statistics delivered to senior management
45
QA Compliance Officer VP Resume Examples & Samples
- Investigating and reporting on opportunities to improve high risk processes and controls performed across CRegO
- Manage the regional elements of the annual QA programme of work
- Work with the wider QA team to understand material compliance risks, which will drive the prioritization of the QA programme globally
- Perform thematic QA reviews, which will follow two distinct methodologies
- Proven experience in problem solving, data analysis and working to tight deadlines whilst achieving good quality outputs
- Structured and organised approach, demonstrating a high level of diligence and attention to detail – ability to ensure high quality and consistency in the deliverables produced
- A positive and flexible approach required to operate in a constantly changing environment
- Experience of building and managing relationships with senior stakeholders, as well as an ability to influence senior stakeholders and colleagues
- Able to work both independently and as part of a global team
- Excellent oral and written communication skills proven through report writing experience
- Strong working knowledge of Microsoft Excel; Word, Visio, PowerPoint
