Site Quality Manager Resume Samples

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AS
A Sauer
Alexandra
Sauer
6216 Harris Loop
Dallas
TX
+1 (555) 394 1120
6216 Harris Loop
Dallas
TX
Phone
p +1 (555) 394 1120
Experience Experience
Dallas, TX
Site Quality Manager
Dallas, TX
Casper, Howell and Schumm
Dallas, TX
Site Quality Manager
  • Partnering with the site leadership team to define and execute business strategies with performance improvement on quality metrics
  • Develop and maintain systems to measure performance against established standards
  • You’re a changemaker: You will deliver new levels of Quality performance through continuous improvement, benchmarking globally and regionally
  • Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process
  • Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view
  • Local Management responsibility to drive improvement of Ratings and Reviews of products developed by the site
  • Development quality management
Los Angeles, CA
MMY Site Quality Manager
Los Angeles, CA
Robel-Walsh
Los Angeles, CA
MMY Site Quality Manager
  • Develop line of sight metrics and manage Quality performance
  • Establish deviation management standards
  • 3) Manage Quality Management Systems
  • Manage and improve document control system
  • Develop a Product Quality Management system though the supply chain
  • Develop an IQC process that works collaboratively between relevant functional groups
  • Work with all sites and business partners to establish an effective communication system
present
Los Angeles, CA
Site Quality Manager, Raleigh
Los Angeles, CA
Kautzer, Friesen and Kovacek
present
Los Angeles, CA
Site Quality Manager, Raleigh
present
  • Schedules employees through subordinates, performance appraisals, and performance management of team members
  • Manages all validation activities for new, altered, or modified equipment, facilities, or manufacturing processes
  • Providing timely testing of production intermediates to assure finished product quality while maintaining production rates; and by
  • Ensures FDA/EU inspection readiness through development of compliance enhancement plans, internal audit program, and industry intelligence
  • Provides direction and leadership for the successful execution of critical quality activities, such as
  • Manages the CAPA program to effectively identify and correct problems that impact product quality or compliance
  • Technical expert in multiple quality functional areas, such as validation, product investigations, quality systems, and establishing compliance plans, etc
Education Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Clark Atlanta University
Bachelor’s Degree in Engineering
Skills Skills
  • In depth knowledge and experience in quality, food safety, microbiology, in an FMCG environment
  • Specific product, ingredient and packaging knowledge to the soft drinks industry is desirable
  • Sound knowledge of food production process and legislation is desirable
  • Strong people leadership skills and ability to integrate differing functional demands is essential
  • Develop and maintain the hardware testing capability
  • FSSC22000 scheme and quality management systems
  • Partnering with the Manufacturing team, measure and monitor all aspects of product/process quality and drive improvement activities as necessary
  • Implementation of Quality processes and adherence to the standards
  • Basic understanding of regulatory and food law, including AAFCO Guidelines
  • ISO Lead Auditor is desirable
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15 Site Quality Manager resume templates

1

Site Quality Manager Lansol Resume Examples & Samples

  • Knowledge of Quality management tools, experience on TS16949 and ISO9001 system
  • Statistical analysis skills
  • Good command of English and computer
  • At least 8 years’ experience in manufacture plant, auto industry and multinational company (JV included) is preferred
  • At least 3 years’ experience of Quality management
  • LI-JW1
2

Site Quality Manager Resume Examples & Samples

  • You have a degree in engineering and have amassed several years of professional experience within quality functions in the chemical or automotive industry
  • You also have experience in positions of leadership, have additional training in quality and are qualified to act as an auditor
  • Beyond that, you also have skills in IT-supported quality tools such as FMEA, SPC and MSA
  • You are responsive toward others and communicate proficiently in German and English in the process, and you strive to bring out the best in every team member
3

Site Quality Manager Resume Examples & Samples

  • Drive continuous improvement through trend reporting analysis and metrics management
  • Assess the adequacy of data gathering methods utilized by the workcells
  • Assure that procedures and work instructions are efficient and not redundant
  • Offer new ideas and suggestions for improvement
  • Demonstrate a commitment to customer service
  • Understand and drive regulatory and compliance certifications as appropriate (i.e. regulatory requirements surrounding ISO9000, ISO14000, TS16949, BABT, TUV, AS9000). Act as the company’s quality management representative
  • Establish new measurement systems if/where possible
  • Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization
  • Ensure 100% adherence to all company policies and procedures
  • Ensure all sensitive and confidential information is handled appropriately
  • Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor
  • Bachelor’s degree required. Master’s degree preferred
  • Seven years experience, including two years in a supervisory role required
  • Or a combination of education, experience and/or training
4

Site Quality Manager, Raleigh Resume Examples & Samples

  • Provides overall direction and leadership of the Site Quality System by
  • Assuring good manufacturing practice compliance for plant and laboratory operations and manufacturing records (includes systems for CAPA, exceptions, document management, complaint handling, supplier quality, OOS investigations, stability programs, and regulatory inspection readiness)
  • Assuring finished product quality
  • Assuring proper use of raw materials
  • Directing sampling and inspection of raw materials and finished products
  • Providing timely testing of production intermediates to assure finished product quality while maintaining production rates; and by
  • Auditing the components to ensure that they operate in accordance with established procedures and regulatory requirements
  • Provides direction and leadership for the successful execution of critical quality activities, such as
  • Ensures FDA/EU inspection readiness through development of compliance enhancement plans, internal audit program, and industry intelligence
  • Manages the customer complaint program, including interaction with customers and resolution of critical issues
  • Manages the supplier quality program to fulfill regulatory and site needs
  • Conducts and/or administers new employee, ongoing, and directed training on GMP topics to ensure compliance to regulations
  • Manages the CAPA program to effectively identify and correct problems that impact product quality or compliance
  • Manages all validation activities for new, altered, or modified equipment, facilities, or manufacturing processes
  • Manages the customer audit process (approximately 50/yr.) to include preparation, hosting, and responding to issues noted – also, utilize input from customer audits and a continuous improvement tool
  • Documents management and label control to fulfill regulatory and business needs
  • Administers the stability program for both API and dosage products manufactured at the site
  • Approves highly technical investigations involving product impact
  • Sets direction and policies for cGMP compliance activities
  • Schedules employees through subordinates, performance appraisals, and performance management of team members
  • Budgets and adherence for areas of functional responsibility
  • Directly interacting with key customers relating to technical issues, potential non-compliance activities, or service issues impacted by quality/compliance
  • Resolution of critical quality issues that could impact production, customer service, quality, or compliance
  • Interprets regulatory guidance to determine site course of action for compliance
  • Technical expert in multiple quality functional areas, such as validation, product investigations, quality systems, and establishing compliance plans, etc
  • Support cost savings and lean initiatives to continuously improve the quality function
  • Working knowledge of chemical, pharmaceutical or bio-pharmaceutical manufacturing
  • Must have knowledge and understanding of applicable global regulations, GMP and compendial requirements
  • Must have thorough knowledge and understanding of QA regulations as they apply to this type of facility
  • Experience in driving improvements in quality systems and quality performance is preferred
  • Certification as a Six Sigma Black or Green Belt and/or as a Certified Quality Engineer is considered a plus
  • Must have high technical ability and excellent interpersonal/communication skills. Requires excellent oral and written skills and good negotiation skills to effectively communicate and influence the outcome of quality related plans, programs, and activities throughout the business unit
  • Must have the ability and experience to drive cost reduction while continuously improving performance, as well as the ability to lead employees in making these changes
5

Site Quality Manager Resume Examples & Samples

  • Prepare Project Quality Plan (PQP)
  • Implement PQP at site and ensure Quality of Works as per standards & procedures
  • Prepare and Implement Inspection Test Plan for the Project
  • Development of Quality performance across the value chain and region
  • Drive improvement in actual QSE performance based on trends and across regions and segments
  • Ensure the QSE performance is understood and part of the business selection process
  • Global contact point for Vestas systemic global needs, including escalation of compliance issues
  • Conduct quality audits at site and coordinate Internal Quality Audits
  • Report Non conformities to Site Manager and implement Corrective & Preventive actions
  • Monitor site documentation as per ISO requirements
  • Coordination with Quality department and site for site quality related issues and resolutions
  • Conduct Mechanical walk down / Construction walk down and coordinate and set benchmarks
  • Participate and witness site Tests
  • Support Meercat Process requirements interms of Vendor Evaluation and feedback
  • Graduate in Engineering & Certification in QMS/ISO9001
  • 8 to 10 years of experience in handling QMS in EPC Projects /Windfarm projects
  • Mongolian driving license preferred
6

MMY Site Quality Manager Resume Examples & Samples

  • 1)Manage and Lead Quality Team
  • Develop, mentor, lead TMs
  • Define, deploy Quality Programs
  • Drive Strategic Quality initiative for the Site
  • Build a site quality team that will drive to zero deviations from product requirements
  • Provide documented performance management for all direct reports with formal and informal feedback, work on a plan jointly to enhance strengths and address weaknesses, and establish performance plan goals with line of sight to IPP goals, MFG initiatives and company strategy
  • Attract top talent to the group as needed to meet operational objectives
  • Develop line of sight metrics and manage Quality performance
  • 2) Mange Product Quality Assurance
  • Deliver a consolidated and aligned focus on improving performance variation and deviations that impact
  • Required product quality
  • Develop an IQC process that works collaboratively between relevant functional groups
  • Develop a Product Quality Management system though the supply chain
  • Provide Customer support (Customer audits, RMAs/Customer Complaints)
  • Provide lot disposition support
  • Collaborate with various stakeholders on NPI
  • 3) Manage Quality Management Systems
  • Facilitate Management review process
  • Manage Closed-loop Internal/External Audit System
  • Promote continuous improvement programs and Quality Culture
  • Manage and improve document control system
  • Drive BKMs and business process alignment
  • Develop a BIC Quality Culture at an appropriate cost
  • 4) Manage Process Control System
  • Develop and sustain Process Control monitor programs
  • SPC
  • FMEA & Control Plans
  • Reduce process and equipment variation
  • Establish deviation management standards
  • Manage ESD Program compliance
  • Drive Change Management compliance
  • 5) Lab Management
  • Provide Failure Analysis support
  • Support Reliability testing execution
  • Ensure compliance to Equipment Calibration requirements
7

Site Quality Manager Resume Examples & Samples

  • Responsible for compliance to mandatory regulatory requirements including Quality Management Systems standards e.g. ISO 9001, ISO 13485, ISO 17025
  • Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view
  • Responsible for the release of product to external and internal acceptance criteria
  • Drive, champion and promote quality practices and behaviours across the site
  • Lead and develop staff within the function to a high level of competency and performance. Set clear, comprehensive expectations demonstrate role model leadership; provide meaningful, timely feedback about performance, train and coach to continuously improve individual performance and business results
  • Prepare and monitor site quality objectives and provide metrics and quality input to the site Senior Leadership Team and the Divisional QRA function
  • Responsible for the health and safety of staff and visitors, including contractors, within the areas supervised and for ensuring that the environment is not adversely affected by the activities of the employees and visitors for whom they are responsible
  • Provide technical and quality support to the business
  • Any other tasks/duties deemed to be within the competence of the post-holder
  • Manage fundamental quality system process to ensure compliance, timeliness and effectiveness e.g. CAPA, change control, audit, management review, supplier control, etc
  • Ensure that all customer complaints are reviewed in a timely manner and escalated appropriately through the vigilance process where required, including notification of reportable events to regulatory authorities
  • Prepare the site for, and host, external audits (customer/regulatory) ensuring corrective/preventative actions are put in place to address non-conformances
  • Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process
  • Ensure that validation system is in compliance with relevant external (regulatory) requirements including ISO, QSR and IVDD
  • Maintain awareness of new relevant regulatory requirements and to alert staff of required system and/or procedural changes
  • Lead the quality engineering practices ensuring partnership with the Operations teams on production issues, training and SOP compliance, root cause analysis, CAPA implementation and other Quality related matters
  • Oversee work scheduling, planning, and general administration of the Product Performance laboratory to ensure targets are met within agreed timeframes
  • Ensure PP testing is carried out in accordance with product specifications and external quality control requirements
  • Monitor, record, analyse and report on activities, trends, results and recommendations relating to product performance and department activities
  • Notify operations director and supply chain of work progress and alert where necessary
  • Liaise with Planning, Purchasing and Marketing to ensure work is prioritised as required
  • Develop and maintain systems to measure performance against established standards
  • Provide information in response to technical enquiries
  • Five years management experience in an IVD Quality Assurance/ environment
  • Knowledge of regulatory requirements including ISO 13485, 9001
  • Degree in a Biological Science or QA discipline
  • Experience in microbiology
  • Quality Control experience/knowledge
  • Experience in QA and IVD/MDD
8

Site Quality Manager Resume Examples & Samples

  • Ensure Customer satisfaction in terms of safety, services, costs of ownership and performance
  • Develop Quality through all the activities of the site by encouraging the quality culture, and promoting the methodologies and results analysis in order help each member of the site to build quality
  • Correctly monitor our processes and products, supervising implementation of appropriate corrective actions and using vetoes as a last protection for the Customer
  • Alert in case of deviation within business that should prevent quality of delivered products and services
  • Manage team members as individuals (appraisals, proposal for promotion, work validation and processes compliance) and as a team (resource management vs project needs, work force / work load management, best practices promotion and sharing)
  • Train and coach team members and other employees in all aspects of Quality Control, Assurance and Improvement
9

Site Quality Manager Resume Examples & Samples

  • Provide quality induction training to the site personnel
  • Lead and manage the site quality team
  • Ensure site documentation is generated, distributed, updated and archived in accordance with the relevant work instruction
  • Provide feedback to on supplier / subcontractors site quality performance
  • Education & Training
  • Mandatory (MUST)
  • Engineering degree / Quality or related qualification
  • 7 years experience in a technical or quality function
  • 3 yeas experience with site quality responsibility
  • Strong problem solving skills
10

Site Quality Manager Resume Examples & Samples

  • Deploy EWC Quality Management System in Rosignano site with the objective to have one single QMS, based on ISO 9001, meeting the requirements and expectations of our customers
  • Work with Rosignano management and operations to ensure understanding and compliance with EWC Quality Management System
  • Support Rosignano teams in day to day implementation, e.g. help identify changes and non-conformity events, prepare quality documents, work with commercial and technical support teams on customer interactions
  • Organize and lead customer visits/audits in Rosignano and ensure quick follow-up and closure of findings and gaps
  • Ensure training in the management systems with own perimeter ans ensure its continuous improvement
  • Ensure the effective audit at customer sites
  • Manage the definition, implementation and follow-up of quality processes for ongoing operations, with a strong link with the GBU Quality group and customer requirements
  • Be the first point of contact for our customers in all terms of quality issues
  • Analyse incidents with respect to quality to identify root cause(s) and initiate effective corrective actions
11

Site Quality Manager Resume Examples & Samples

  • Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements
  • Manages and develops Quality team according to Thermo Fisher Scientific policies and processes
  • Timely completion and follow up through to closure of CAPA actions
  • Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities
  • Actively contribute to the success of the overall QA team and the site
  • Bachelor’s Degree in a Scientific/Technical field (i.e. Chemistry, Biology, or Engineering)
  • Direct man management experience in Quality function
  • Analytical ability is required to make competent decisions based on a review of analytical data
  • Approximately 10-15% travel may be required
  • Experience in a Regulated Quality environment, e.g. ISO13485
  • Management of individuals
  • Audit experience (as Auditor or Auditee)
12

Site Quality Manager Resume Examples & Samples

  • Manage any Raw Material receiving and laboratory operations within budgeted costs, productivity objectives and quality standards
  • Prepare, study, participate to decision, manage and validate technical works and process revisions made internally or by external companies
  • Provide tools, expertise, training and assistance: SPC “expert”
  • Prepare annual operating budgets and participate to the definition of the Capital Investment Budget
  • Manage designated investment projects (Budget, time table, external companies’ intervention…)
  • Manage plant health and safety within RM receiving & Laboratory Department
  • Manage environment protection within RM receiving & Laboratory Department
  • Continuously audit the plant in order to assess for asset protection (fire protection)
  • Pest Control and sanitation (cleanliness) Programs
  • Provide advices and perform active survey for new federal or provincial laws and/or regulations
  • Audit the local raw material / packaging material suppliers in relation with NA Purchasing Department and Supply Coordinator
  • Periodical quality and performance audits for guaranteeing the food safety and the transfer of the R.C. improvement tools / Royal Canin needs
  • Audit reports
  • Participate to continuous improvement within supplier organization
  • Previous experience in food / feed process industry
  • English: read, written, spoken
  • Fully functional Microsoft Office
  • Good communication, Cost conscious, Initiative, Etiquette skills, Self-motivated, Team player, Safety & Hygiene & Quality conscious, Technically inclined, Unrestricted range of motion, Color discrimination, Olfactory & texture perception, Depth perception, Tolerance to hot environment, Able to work various shifts, Able to climb stairs repeatedly, Not afraid of heights
13

Site Quality Manager Resume Examples & Samples

  • Champion quality standards and legal compliance within the operations teams
  • Co-ordinate coaching, training and information to enable the site teams to deliver their quality and food safety role requirements to a competent level
  • Lead quality incident investigations to establish root cause and corrective and preventive actions
  • Lead all site activities to prevent and control all non-conformances, internal or external through quality processes
  • Proactively identify, review and take ownership for improvement through zero loss
  • Oversee the verification and maintenance of process and quality control equipment
  • Lead 3rd party accreditation standards for all external and internal audits for the Site
  • Maintain good relations and keep contact with any regulatory bodies associated with the quality function
  • Support the GB&I Operations Development team with the implementation of change projects
  • In depth knowledge and experience in quality, food safety, microbiology, in an FMCG environment
  • Strong people leadership skills and ability to integrate differing functional demands is essential
  • Proven people management skills with ability to flex styles to differing individual needs is essential
  • Sound knowledge of food production process and legislation is desirable
  • Proven experience of people development and performance management
  • Specific product, ingredient and packaging knowledge to the soft drinks industry is desirable
  • Implementation of Quality processes and adherence to the standards
  • Intermediate HACCP
  • Intermediate Food Hygiene
  • ISO Lead Auditor is desirable
14

Site Quality Manager Resume Examples & Samples

  • 5+ years as Superintendent with degree, or 7+ years w/o degree
  • Engineering or Construction Management degree
  • Advanced Knowledge of construction technology
  • Basic Knowledge of EPC industry
  • Intermediate Constructability knowledge
15

Site Quality Manager Resume Examples & Samples

  • Partnering with the site leadership team to define and execute business strategies with performance improvement on quality metrics
  • Work with quality champion(s) and other operating leaders to develop project deployment strategy, goals and priorities
  • Collaboration with the quality interfaces in the project (internal partners, suppliers, subcontractors and customer)
  • Monitor subcontractor quality performance and provide support on issues raised at site, perform quality kick-off meetings with sub-contractors at site prior mobilization
  • Improve customer satisfaction and reduce process variation through application of Lean at site
  • Define scope and support/coach improvement projects (PDCA, 8D, RCA, A3, DMAIC, VSM, etc.)
  • Drive compliance during execution work at site (Civil, M&E, Commissioning) with GE processes
  • Implement the Site Management File (site procedures), deploy & monitor related site indicators (KPIs)
  • Ensure management & control of documentation at site
  • Conduct internal audits as part of the global SPS and the local site audit program
  • Capture lessons learned to continually improve execution processes (REX), seek, share and institutionalize best practices
  • Define the Quality Control strategy and implement a robust notification system on witness points
  • Management of NCRs and CoPQ analysis and improvement
  • Deliver site Quality documentation on time
  • Monitor project and process compliance vs internal standards/instructions and external requirements, escalation of any non-compliance
  • Communicate progress, status and issues to champions and operational leaders
  • Implement governance through management cycles
  • Build the budget of the department and monitor the expenses per budget authorization
  • Promote the interests and image of the company at any times
  • Behave per GE code of ethics and beliefs
  • Proven years of industrial experience in quality
  • Engineering / science degree from university or equivalent knowledge & experience
  • Quality, manufacturing, engineering and supply chain skills
  • 8D problem resolution, FMEA and other quality tools
  • Customer-focused in defining quality and establishing priorities
  • Ability to deliver effective presentations and educate at all levels of the organization
  • Ability to influence cross-functional business teams and drive quality improvements
  • Qualification in welding inspection and non-destructive tests
  • Ability to travel regularly
  • Experience in Welding / Painting / Civil Work / Mechanical Erection / Commissioning / Electrical Systems
16

Site Quality Manager Resume Examples & Samples

  • You’re a born leader: Your success will be based on the success of your team, the extended factory team, and the efforts they lead
  • You’re a dot connector:You will educate employees at all levels on Food Safety Programs, Regulatory requirements, and connect our programs to the everyday activities and actions of the team
  • You’re a changemaker: You will deliver new levels of Quality performance through continuous improvement, benchmarking globally and regionally
  • You’re a culture & change champion: You will inspire a culture where employees are passionate about the consumer experience and find ways to infuse quality and food safety into their work
  • 3-5 years experience in Quality or Manufacturing. Food manufacturing experience preferred
17

Site Quality Manager Resume Examples & Samples

  • Manages all quality assurance and laboratory (technical services) functions for the site
  • As a member of the site staff, participates in and influences the development and implementation of site strategies
  • Provides direction and influence for the development, implementation and continuous improvement of all quality systems
  • Assures that all products and packs produced at the site are safe for consumption and conform to the intended product design. This includes being responsible for actively supporting change management and process improvement as the R&D Quality Champion
  • Supports the quality and product safety components of all R&D driven projects at the site through quality planning, and by project oversight for compliance to GMP’s and other company policies and standards
  • In partnership with the brand teams, supports the site implementation of all new products, line extensions and continuous quality improvement projects including the effective execution of line trials and execution of process capability evaluations
  • Manages the internal quality audit function for site and assures the effectiveness of the corrective and preventative action process within the framework of the plant’s Quality Management System
  • Represent the “owners” of the Mars business at the site with respect to the quality and safety of products and the food processing environment. This responsibility includes participation in the management of crises involving products, and the timely communication of the investigation results through R&D and Supply. Also responsible for the on-going interpretation and reporting of information from our customers and consumers, and the identification and analysis of trends, which may trigger an investigation
  • Manage QFS Technologists in the site to assure skills development and build clear succession planning, manage daily attendance, and associate development plans. Provide timely feedback on performance and provide training opportunities which align with development plans
  • Ensure adherence to the Mars Global Quality and Food Safety Standards
  • Recommendation for food safety decisions that can have catastrophic impact to consumer protection and Brand image
  • Support field retrieval of product that could result in significant financial business impact
  • Product conformance to specifications and requirements
  • Notification of product quality and safety issues; identifying business risks and expedient communication of issues
  • Approval of change management activities
  • Staffing requirements and changes in alignment of resources
  • Management of site quality budget
  • Execution and planning of internal audit and CAPA program (budgeting, resource allocation, etc.)
  • Technical training requirements for the team and their individual development plans
  • Local equipment purchases, including laboratory instrumentation
  • Recommendation for line operation shut down due to product quality or safety issues in the process or site environment
  • Product dispositions for held items
  • As a staff member, participate in the development and implementation of site strategies
  • Local quality systems projects for site improvement
  • Laboratory analytical support required to troubleshoot and resolve site issues
  • HACCP and food safety management
  • FSSC22000 scheme and quality management systems
  • Project & Change Management Processes
  • Word, Excel, and PowerPoint
  • Integrated Sanitation and Pest Control Management
  • GMP and Personnel Hygiene Management
  • Minimum 1 years of experience as a manager of people
  • A Bachelor’s degree in Chemistry, Food Science, Engineering or related technical field is required
  • A minimum of 3 years of experience in a technical area such as R&D, product development, laboratory management, quality management systems, or food process engineering
  • Experience effectively leading a team and accomplishing goals through others
  • Basic understanding of regulatory and food law, including AAFCO Guidelines
  • Advanced degree is desirable
18

Site Quality Manager Resume Examples & Samples

  • Manage a mix of RUO (ISO 13485 & ISO 9001) and cGMP Quality operations which includes Quality Assurance, Quality Management System, and Quality Control - monitoring and acceptance of incoming raw materials through final production release. Assure compliance to corporate standards and industry standards
  • Manage the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, and manufacturing area support
  • Accountable for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulations (QSR, Part 820)
  • Ensure effective transfers of new products into production that meet all the Quality requirements for the classification
  • Coordinate the development of action plans when corrective steps (CAPA) are required and implements these through the site steering team. Responsible for routinely managing, tracking and reporting Critical Success Factor metrics to support plant Quality initiatives
  • Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective
  • Assist in overall GMP strategy for the site, understanding best practices, and guidance from other GMP sites across the globe and supporting the implementation
  • Lead and inspire the Quality team
  • Build and maintain effective working relationships across all functions
  • Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering)
  • A minimum of 5-10 years of management experience in Quality, prefer experience in a GMP or similarly regulated facility
  • Requires thorough knowledge of cGMPs for medical devices or pharmaceuticals
  • FDA audit experience with successful outcomes
  • IND_LSG
19

Site Quality Manager Resume Examples & Samples

  • Prepare Project Quality Plan (PQP) and implement across the project
  • Review & comment on Inspection Test Plans (ITPs) on complete project scope
  • Manage all ITPs towards suppliers, subcontractors & customer
  • Plan and perform inspections at Site and at Suppliers as per approved ITPs
  • Coordinate & perform and Witness Tests at Site or at Factories as per ITPs
  • Conduct ISO QMS audits as and when needed to improve performance
  • Manage NCR process internally & externally
  • Ensure all Quality Records are processed and archived as per respective procedures
  • Conduct Mechanical Walk Down and final inspections
  • Support Vendor Qualification Process in respect to process & product
  • Graduate in Engineering & Certification in QMS/ISO
  • 5 to 10 years of experience in handling QMS, QA, & QC in EPC Power Projects
  • Hands on experience in EPC Projects
  • Experienced in Basic Tools for Quality, e.g. 6 Sigma, Ishikawa, Pareto, etc
20

Site Quality Manager Resume Examples & Samples

  • Bachelor of Sciences in Pharmaceutical Sciences
  • Having a Certification as a “First-Class pharmacist” per the Drug Act B.E. 2510
  • At least 5 years of experience in a pharmaceutical manufacturing environment
  • Good communication and problem-solving skills
  • Good English and computer skills
  • Good team player with teamwork mindset
  • Being an active listener and proactive in activities/assignments