QA Validation Resume Samples

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D Haag

Dangelo

Haag

408 Dayna Port

Dallas

+1 (555) 997 6701

408 Dayna Port

Dallas

Phone

p +1 (555) 997 6701

Experience Experience

Los Angeles, CA

Coordinator QA Validation

Los Angeles, CA

Rodriguez Group

Los Angeles, CA

Coordinator QA Validation

Develop and continuous improve expertises linked to the validation activities : expert on the field, technical and regulatory watch over
Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up
Be a strong advocate for validation approaches and activities during internal and external audits
Use a risk based approach for problem solving and prioritization of tasks
Problem solving and innovation
Write some validation (VP, PV, VSR, PVMP, RA, GA) documentation according to the GSK Vaccines standards and procedures
Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations

San Francisco, CA

QA Validation Specialist

San Francisco, CA

Lebsack-Rodriguez

San Francisco, CA

QA Validation Specialist

Working knowledge of Microsoft Office Suite, FileMakerPro, and Kaye Validator
May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines
Manages projects and prepares status reports
Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Aids in investigations and troubleshooting as part of a multi-functional team to determine solutions or recommendations for changes and/or improvements
Development of Quality Systems and procedures to support facility start-up

present

Detroit, MI

QA Validation Project Manager

Detroit, MI

Rohan-Gleason

present

Detroit, MI

QA Validation Project Manager

present

Continuously drive to improve processes for improved performance
Develop strategy and create metrics to measure effectiveness of strategy
Resolves problems, identifies issues and determines system improvements
Manage internal and external relationships
May manage others through influence rather than direct authority
Lead special projects as assigned by the Senior Manager
Manage and drives projects and programs

Education Education

Bachelor’s Degree in Automation

University of Tennessee

Bachelor’s Degree in Automation

Skills Skills

Strong knowledge of quality systems
Strong knowledge of Good Documentation Practice
Strong knowledge of cGMPs for pharmaceuticals/biotechnology
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Strong knowledge of cGMPs for biotechnology
Ability to work independently or as part of a team
A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability
Ability to communicate with transparency
Ability to work independently and as part of a team
Working knowledge of Microsoft Office Suite, FileMakerPro, and Kaye Validator

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15 QA Validation resume templates

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QA Validation Manager Resume Examples & Samples

5+ years of experience in Validations within a Pharmaceutical Manufacturer
Bachelor's Degree in a Scientific field
Previous experience in a Supervisory position
Experience in solid-dosage manufacturing (granulation, drying, milling, blending, tablet compression, pan coating, fluidized bed processing, tablet printing, encapsulation)
Knowledge of pharmaceutical GMPs and regulatory requirements
Microsoft Office/Suite proficient (Word, Excel, PowerPoint, Access, etc.)

QA Validation Specialist Resume Examples & Samples

Responsible for drafting, reviewing and approving commissioning and qualification documentation for new systems and equipment. This may include the development of user and function requirements, support of factory/site acceptance testing, commissioning, and development of performance qualification documents
Assisting in determining project schedules and the relevance of appropriate levels of validation
Ensuring Data Integrity per 21 CFR Part 11 / Annex 11 Requirements
Process validations against corporate SOP/FDA/EMEA requirements
Understanding and applying industry specific compliance standards/regulations to all CQV activities
Validation functional testing and tracking and resolution of exceptions during qualification activities
Development of project plans for Validation/Qualification projects
Proactively highlighting any issues around compliance
Generation and signing off of protocols, reports, project change controls and deviations
Development of Quality Systems and procedures to support facility start-up
Must be able to analyze data using basic statistical methods
Good interpersonal skills are required, as is the ability to communicate well, both verbally and written. Must be able to function effectively in a teamwork environment
The incumbent should possess knowledge of cGMP requirements for pharmaceutical manufacturing
The individual in this position is expected to represent interests, objectives and policies in a professional and responsible manner
The individual must demonstrate an ability to work independently
Bachelor's Degree in engineering or scientific discipline preferred plus10 years' experience working as a Quality or Validation Engineer in a cGMP manufacturing environment

QA Validation Associate Director Resume Examples & Samples

Ensuring a robust quality system is in place for facility, equipment & lab instruments, engineering, maintenance, supply chain, computerized systems and validation activities which comply with global regulatory requirements, industry best practices and will successfully withstand regulatory inspections by regulatory authorities
QA Oversight and support of Product technology transfers, participation in CMC teams
QA oversight of change control for manufacturing systems – including Facility/equipment projects
QA Oversight of qualification, computer system validation, cleaning validation, and process validation
The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products as well as emerging products and platforms

QA Validation Specialist Resume Examples & Samples

Participate in various initiatives supporting the validation of processes, utilities, equipment, test methods etc., in order to transfer knowledge into production for future handling
Support improvement of the validation process in general in Dako. (QMS18 and associated TP’s and TX’s.)
Participate in projects transferring new manufacturing processes to production, having focus on the validation issues
Experience in quality management, ISO 13485, 21CFR820 (FDA)
Extended knowledge of the rules and requirements in the change control process
Strong knowledge of Good Documentation Practice

Supervisor, QA Validation Resume Examples & Samples

Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results
Supervises team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
Supervise, provide direction and assign work to Validations Specialists to meet goals and timings
Participates in regulatory and customer activities
Collaborates with functional departments to resolve issues
Manages projects and prepares status reports
Supervises Specialists and Technicians
Ability to comprehend regulatory requirements and technical documentation and objectively make decisions
High level of emotional maturity and self-confidence
Working knowledge of Microsoft Office Suite, FileMakerPro, and Kaye Validator
Familiarity with scheduling software
Strong knowledge of cGMPs for biotechnology
Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education
Experience in Supervisory position or lead position preferred

QA Validation Project Manager Resume Examples & Samples

Review of validation documentation associated with initial and continuing CTU qualification, equipment qualification, cleaning/steaming validation, continuing assessments, MicroClean qualification, change controls, method and assay validation
Responsibility for API process validation reviews and approvals in preparation for late stage and commercial operations
Lead special projects as assigned by the Senior Manager
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the field of Biotech Process sciences, Validation, Manufacturing
Experience in cGMP operations and process validation is required
Process validation experience preferred. Equipment qualification and/or cleaning validation experience a plus

QA Validation Specialist Resume Examples & Samples

Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
Trains/advises less experienced Specialists and Technicians
BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 1 year related experience within the field preferred; may substitute relevant experience for education
Ability to comprehend regulatory requirements and technical documentation
Strong knowledge of cGMPs for pharmaceuticals/biotechnology
Level will be determined based on skills and related experience.*

QA Validation Associate Resume Examples & Samples

BS/MS degree in science, engineering, or related field with 2+ years of relevant industry experience in Quality Assurance, Quality Control, Process Sciences or Manufacturing
Working knowledge of cGMP andthe ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance is required
Familiarity with analytical method and/or process validation from either a technical or quality standpoint
Enthusiasm and ability to proactively implement continual improvements
Ability to organize information in a consistent and readily retrievable manner
Position may require some travel; ability to travel is required
Proven ability to work effectively in a fast paced team environment
Familiarity with change management systems is desired
Prior experience in cleaning validation and shipping validation is a plus
Experience and/or industry training in process monitoring and ability to apply statistical principles in a pharmaceutical setting to support process validation is a plus
Prior experience applying risk assessments to validation projects is a plus

QA Validation Specialist Resume Examples & Samples

Generation and signing off of protocols, reports, and project change controls and deviations
Bachelor's Degree in engineering or scientific discipline preferred plus10 years experience working as a Quality or Validation Engineer in a cGMP manufacturing environment
The individual in this position is expected to represent the companies interests, objectives and policies in a professional and responsible manner

QA Validation Specialist Resume Examples & Samples

Generates, executes, reviews, approves, master and completed qualification/validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Prepares equipment for qualification studies, executes qualification and validation studies according to approved protocols and SOPs
Initiates, reviews, edits and approves change control and SOPs
Day to day management and oversight of sterilization contract specialists
Assesses quality system documentation for completeness and accuracy, and dispositions documentation per Regeneron SOPs
Extensive experience in Steam Sterilization of biopharmaceutical process equipment
Requires a BEng/BSc in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required

QA Validation Manager Resume Examples & Samples

Bachelor’s degree in a scientific discipline or four (4) years of experience in lieu of degree. Master’s degree preferred. Foreign degrees must be evaluated for U.S. equivalency
A minimum of six (6) years of progressively responsible job related experience including two (2) years of experience in a leadership capacity
Experience in a cGMP environment (biologics preferred)
Experience managing equipment validation projects
Experience managing calibration activities
Experience supervising contractors
Ability to establish a validation strategy to manage multiple projects effectively and efficiently
Knowledge of current regulatory expectations and industry standards relating equipment validation and calibration requirements
Working knowledge of quality systems
Project Management Professional (PMP) certification

QA Validation Technician Intern Resume Examples & Samples

Must have strong communication skills, ability to multi-task, and ability to work effectively in a collaborative environment
Preferred Course of Study: B.S. Biological or chemical sciences. Can also include engineering disciplines that interface w/ biology or chemistry
General academic lab experience of 2+ years is required. Experience in one or more of the following areas: Protein processing, chromatography, nucleic acid experience, development work

QA Validation Specialist Resume Examples & Samples

Generates, and/or reviews and approves master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Reviews, edits and approves test plans for change controls
May train/advise less experienced Specialists and Technicians
BS/BA in Engineering, Chemistry, or Life Sciences with 4+ years of related experience within the field preferred; will substitute relevant experience for education

QA Validation / IT Manager Resume Examples & Samples

Responsible for operational management, planning, of the AUST Computer Validation program and QA validation initiatives. Develop validation test strategies and plans that provide adequate consideration of risk associated with business and technical drivers
Provides subject matter expertise (SME) on all aspects of the computerized systems lifecycle and validation principles and practices across all disciplines
Provide CSV oversight for all AUST computer validation projects to ensure that test deliverables are completed per internal / global guidelines and per Stakeholders expectations
Oversees AUST and QAA CSV projects to assure a quality output as well as compliance with global SDLC / CSV and applicable regulations
Manages the implementation of computer system change controls for Global Serialization Systems, SCM SAP, ADMS Technology, and others to track and monitor validation/revalidation activities
Collaborates closely with AUS IS Organization to insure compliance to internal/global procedures and applicable regulations
Provides leadership in driving a consistent computer system validation approach across the Astellas regions and provides support, technical guidance and advice to global teams in regards to SDLC/CSV requirements
Supports SDLC/CSV validation strategies and documentation collection during internal audit and third party inspections
Reviews and approves over hundred (100+) system development life cycle and computer system validation documents per year
Coordinate support staff of multiple external and internal team members
May lead direct reports and/or contractors and provide supervision and coaching to these individuals
BA / BS or equivalent, science-related preferred, with a minimum of 7 years of Pharmaceutical industry experience in computer system validation
In-depth knowledge of GxP regulations (e.g. Part 11 compliance) and computerized system validation in Pharmaceutical GxP regulated environment with a broad knowledge of quality principles and industry trends
Effective written / oral communication and interpersonal skills with an ability to effectively work across the Astellas group and with external/internal stakeholders to maintain effective relationships
Ability to apply industry knowledge and interpretation of regulations to anticipate global impact for CSV strategies to a variety of management levels
Ability to proactively predict and resolve complex problems, provide strategic and tactical thinking, and build consensus across a global organization
Working knowledge of validation requirements for Supply Chain SAP and Serialization Track and Trace System. Strong validation protocol writing skills
LI-BR

QA Validation Associate Resume Examples & Samples

Provide project management oversight for validation activities related to BioMarin’s products and facilities, utilities, equipment (FUE), and CSV
Developing validation plans for specific system implementation projects
Execute (protocol generation, execution, and final package preparation) validation activities related to the implementation of facilities, utilities, equipment (FUE) changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions
Review of IT-CSV documentation relating to Software application projects
Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, Validation techniques/approaches and systems utilized at BioMarin
Lead and represent Validation in multi-departmental meetings & project teams
Identifies and implements improvements to the QA Validation systems
Participation in the change control program for modifications to qualified systems
Coordinate Validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
2 years experience in a cGMP regulated manufacturing environment, with knowledge of equipment validation and laboratory systems / validation
Knowledge of CSV validation would be an advantage
Organizational and management skills to coordinate multi-discipline project groups
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations

QA Validation Intern Resume Examples & Samples

1) Rapidly gains knowledge and of cGMPs, pharmaceutical manufacturing methods and validation principles desired
2) Assists in achieving validation study objectives/schedules while working across multiple departments
3) Assists in the preparation of scientifically sound validation protocols that incorporate the defined specifications into acceptance criteria and assessment procedures
4) Assists in the preparation of test equipment and execution of validation studies (cleaning, process, steam sterilization, temperature mapping, and equipment requalifications, etc.) in a manufacturing environment
5) Effectively communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to the needs and status of assigned study execution activities
6) Assists in the collection, interpretation, and evaluation of validation test data for conformance to validation acceptance criteria and/or to investigate and determine root cause for validation study discrepancies
7) Assist in the preparation of detailed, concise reports on completed studies that summarize the studies experimental results and their conformance to defined acceptance criteria
8) Researches governmental regulatory requirements and industry guidance on assigned projects
9) Other tasks as required by Departmental Management

Specialist, CSV QA Validation Resume Examples & Samples

Autonomy
Critical mind
Fluent in French & English
Specific Knowledge
Manage QA activities related to the following Quality systems: Change Control, Deviations, CAPA, periodic review, …
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
Coach the User, Technical Services and other QA departments in the GSK methodology applied to automated and computerized systems

QA Validation Resume Examples & Samples

Scientific university degree (pharmacist, Engeneer or equivalent)
Minimum 2 years of experience in a pharmaceutical/BIO/Medical device environment or equivalent
Knowledge of GMP regulated environment, process/equipment validation and aseptic environment
Good knowledge of English
Ensure quality oversight of all validations activities (IOQ/PQ, …)
Ensure deviations and change controls are reviewed and handled in timely manner
Ensure critical topics are adequately and timely escalated to higher management
Represents QA in all validation meetings related to the area of responsibility
Performs internal audits, shopfloor, gemba’s and effectiveness check
Performs Risk assessment, GAP analysis, periodic review, validation plan and validation summary reports
Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirement
Understands validation/technical problems and evaluates their potential impact on product quality. Escalates complex problems to N+1

QA Validation Manager Resume Examples & Samples

Preparation of validation documents (study design/ writing protocols and reports)
Support R&D teams during the process qualification phase
Support operations assessing changes and deviations
Preparation and maintenance of a documented control strategy
PQRs: Review, validation assessment and final approval

Associate, QA Validation Resume Examples & Samples

Applies existing validation programs for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems
Maintains validation programs for existing equipment, utility commissioning and qualification, and computer systems
Drafts, reviews, and executes protocols and reports related to equipment, facility, method, computer, and process validation. This includes deviation reporting during execution
Acts as a quality contact for Validation, including Computer System Validation (CSV) and Quality Risk Management
Ensures that the site Validation Master Plan remains current and aligned with corporate policies
Provides statistical support for Quality Systems monitoring and review
Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to ensure impact on validated systems
Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
Performs special projects as directed by management
Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or
Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of two years’ related experience

QA Validation Specialist Resume Examples & Samples

Master degree or PhD: Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline
3-5 years in Pharmaceutical industry, with specific experience in a quality and/or validation role and knowledge of quality systems and vaccines regulations
Very good knowledge of French and English
Knowledge of good practices in biopharmaceuticals,
Knowledge of different regulations and standards related to validation activities,
Maintain and keep up to date its knowledge and experience necessary to the function,
Good team player in order to success in each validation project,
Good interpersonal relationship skills,
Compliance Authority of SOP, transversal CAPA / transversal risk & issues, involvement in validation deviation and voice of the site regarding validation
Accountable for system effectiveness review of validation system with the SSM to meet GMP requirement
Support model in complex and transversal areas linked to validation
Review and participate in the improvement of the Global Standards, Technical Standards, to enhance compliance, standardization and simplification
Support the technical support and knowledge to MPU/SPU’s to guarantee manufacturing and quality validation are designed and executed to deliver expected product quality, as well as robust, sustainable operations
Support discipline engineer of BeEM in the project for subject linked to validation

Stage QA Validation Resume Examples & Samples

Master Degree in CTF, Biotechnology or Chemical engineering
Proficient in English and Italian: written and spoken
Good knowledge of Microsoft Office, with focus on Excel and Power Point
Collaborative approach and ability to interact with other group members
Ability to learn and to adapt quickly
Teamwork: Work effectively in a cross-functional environment
Dynamic and pro-active attitude

System Test SW QA Validation Engineer Internship Resume Examples & Samples

Help configure System Test applications and architectures using physical and virtual computer infrastructure
Edit and author test cases including testing scripts
Help develop System Test tools and utilities to increase the effectiveness of the team and R&D organization
Work with cross-functional product development teams (product management, program management, system architecture, sales, business development, and product quality control) to help achieve high value business outcomes
Professional or academic experience in building and/or testing distributed client/UI and server software using C/C++/C# on Windows Platforms. Experience with COM/DCOM/.NET and SQL Server based applications
Some experience with XML, DOS command line/.bat and PowerShell scripting to automate repetitive tasks
Experience with virtualization technologies including VMWare (ESX, VSphere, VCloud), Microsoft Hyper-V and Microsoft Azure
Knowledge of SOA (Service Oriented Architecture) based enterprise products
Familiar with software lifecycle processes and methodologies, with emphasis on quality assurance, testing and security best practices
Strong technical/engineering background and currently enrolled in a program for a Computer Science or other Engineering degree
Strong verbal and written communication skills, with ability to articulate the problem and solution space to different types audiences (Technical, Sales, Executive staff etc.)

Senior Project Leader QA Validation Oversight Resume Examples & Samples

5 years of experience in any of the following: Process, Equipment, Computer, Utilities, Cleaning Validation and Change Controls
Knowledge of cGMPs, FDA and other Regulatory requirements
Experience reviewing and auditing Process, Equipment, Cleaning and Utilities Engineering Validation documentation for compliance
Review and approve all Process, Equipment, Cleaning and Utilities Validation Protocols for compliance to internal
Process Validation Program requirements
Review and approve all Process, Equipment, Cleaning and Utilities Engineering Validation Quality/Deviation
Assessments for impact to the state of Process Validation
Participate on EI Teams as required to provide QA Validation Impact Assessments and Compliance guidance
Review and approve all Critical Documents, Critical Change Control Requests/Assessments for impact to the state of Process, Equipment, Cleaning and Utilities Validation, as well as site compliance
Periodically audit all Process, Equipment, Cleaning and Utilities Engineering Validation documentation for compliance to all internal/external Regulatory Policies and Guidelines (cGMP’s, SOP’s, NDA’s, GQP/G’s, Technical Dossiers,

QA Validation Engineer Resume Examples & Samples

Independently applies quality principles to projects, reviews, document approval and problem resolution
Serves as the subject matter expert (SME) for the validation, revalidation, and change control programs for clinical and commercial products
Independently develops validation strategies for new projects that are consistent with the company’s validation policy, programs, and procedures, regulatory agency expectations and industry best practices/guidance
Manages and monitors projects and coordinates the efforts of multiple groups within the company and with external contract organizations
Ensures all applicable compliance standards are achieved; may present validation strategies and projects during regulatory inspections
Demonstrate a thorough knowledge of manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends for biological products
Assists with periodic review of validated systems
Works independently, organizing and managing projects
Bachelors Degree in an engineering or life science discipline, or equivalent experience
A minimum of 8 – 10 years of relevant QA/validation experience
Experience with both clinical and commercial products
Experience defending validation practices during regulatory inspections
Knowledgeable of relevant regulatory guidance and industry best practices
Experienced with MS-Word, Excel, Project, PowerPoint, and Visio
Strong interpersonal and communications skills, ability to work well with others
Excellent technical writing and analytical skills

QA Validation Specialist Resume Examples & Samples

Will have and provide quality oversight on the validation of equipment, instruments and automation in the manufacturing facility. Will have and provide quality oversight on the validation of process utilities
Quality Approver on installation qualification, operational qualification and performance qualification protocols and reports for equipment, instruments and automation in manufacturing facility
Contributes to the creation of team based, collaborative environment promoting candor and receptivity, clarity of purpose and goals, and high commitment to achieve business goals
Identifies issues within and outside area of responsibility. Evaluates options and presents solutions to manager. Leads efforts to resolve the issue
Will be expected to cross train and develop their expertise in other areas of validation, such as analytical instruments, method validation, process utilities, etc
Personnel must have knowledge and experience of any of the following is required: operation and validation of processing equipment, operation and validation of process control systems (DCS and PLC)
Must have effective verbal and written communication skills
Must demonstrate multitasking and organizational skills
Must be able to interact and lead effectively in a team based environment
Attention to written detail is essential

QA Validation CSV Specialist Resume Examples & Samples

Bachelor or Master degree in automation, engineering, IT, sciences or equivalent by experience
Minimum 3 years or relevant experience with at least 1 years experience in a computer systems validation role
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
Technical knowledge of automated and computerized systems
Manage team of 2-3 consultants (coordinate activities, interact with other departments on the GSK methodology, …) to maintain the validated status of automated and computerized systems used to produce vaccines
Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology
Reviewing and approving of CSV specific SOP’s and Templates
Support team and management during internal and external audits
Report to QA CSV Manager

Temp QA Validation Specialist Resume Examples & Samples

SIP thermocouple placement for steam sterilisation and steam sanitization
Specifically focused on the SIP Validation activities, to support the QA Validation Lead in that area
Reviews, edits and approves reports, such as automation performance evaluation reports, and other reports or documentation submitted to the department
Trains less experienced Specialists and Technicians
Assesses quality system documentation for completeness and accuracy, and dispositions documentation within Regeneron SOPs
Generation of KAYE reports
Experience and usage of KAYE validator software is an advantage

Temporary QA Validation Specialist Resume Examples & Samples

Aids in investigations and troubleshooting as part of a multi-functional team to determine solutions or recommendations for changes and/or improvements
Reviews, edits and approves change control and SOPs
Reviews, edits and approves reports, such as, Automation performance evaluation reports, and other reports or documentation submitted to the department

QA Validation Specialist Resume Examples & Samples

Trains/advises less experienced Specialists
May be required to oversee contingent workers
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Gathers and organizes information
Meets commitments on time
Follows directions; performs well-defined tasks
Seeks to identify continuous improvement needs
BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education

Coordinator QA Validation Resume Examples & Samples

Minimum 2 years of experience in a pharmaceutical/Bio/Medical device environment or equivalent
Very good knowledge of English
Knowledge of GMP regulated environment
To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan(CVP),
To support the production & technical services teams in the implementation of the validation activities,
Write some validation (VP, PV, VSR, PVMP, RA, GA) documentation according to the GSK Vaccines standards and procedures
Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations
Problem solving and innovation
A knowledge of good practices in biopharmaceuticals,
A knowledge of different regulations and standards related to validation activities,
To maintain and keep up to date its knowledge and experience necessary to the function,
Nature of interactions
To be a good team player in order to success in each validation project
Impact
In terms of people involved in the validation project
In terms of equipment usage during validation project
In terms of production batches used for validation studies
In terms of operational expenses related to the validation studies

QA Validation Project Manager Resume Examples & Samples

Generates executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
May prepare equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
Provides direction and assigns work to full time employees and contingent workers to meet goals and deadlines. Coordinates with other departments or outside contractors/vendors to complete validation tasks
Manage and drives projects and programs
Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. SIP Qualification, Cleaning Validation, Lab Equipment Qualification, Cleanroom Qualification)
May include other responsibilities as required by business needs
Ability to communicate with transparency
Demonstrate respectful behavior at all times
Accountable for technical performance and results of team
Manage internal and external relationships
Translate ambiguity into actionable steps
Handle issues appropriately and with a sense of urgency
Ability to communicate at all levels and across various functions
BS/BA in Engineering, Chemistry, or Life Sciences with 10+ years of related experience within the field preferred; will substitute relevant experience for education

QA Validation Specialist Resume Examples & Samples

Generates, executes, reviews, and approves master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Completion of CFR Part 11 Assessments
Working knowledge of Microsoft Office Suite and LIMs
Familiarity with qualification requirements for QC laboratory equipment such as HPLC, pH meter, conductivity analyzer, balances
Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required

QA Validation Specialist Resume Examples & Samples

University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
At least 5 or 8 years of experience in a pharmaceutical / biotech / medical device / food industry or equivalent environment as Manufacturer, Engineer, Validation expert or Quality Assurance
Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
Relevant quality experience or validation experience (not necessarily within a quality department)
Experience with clean or aseptic would be appreciated
Good knowledge of different regulations and standards related to validation activities
Demonstrated impact and influence
French speaker with good level of written and spoken English
Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Bio standards and procedures
Participate to external audit as appropriate
Implement change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Quality within the MPU
Apply lean sigma across the teams to ensure continuous improvement
Share and integrate best practices within the Vaccines Quality Network

Associate QA Validation Project Manager Resume Examples & Samples

Coordinates with other departments or outside contractors/vendors to complete validation tasks
May trains/advise less experienced personnel
May directly supervise contingent workers
Must be able to present in a “pressure test” scenario the technical area that they are SME for
May present at both internal and external (regulatory) audits
Stays current with industry trends, regulatory requirement updates, and drives changes and improvements based on trends
Ability to work independently or as part of a team
May manage others through influence rather than direct authority
Ability to resolve conflicts and coach others on problem solving
Prioritize based on business needs
Identify and effectively communicate risks
BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; will substitute relevant experience for education