QA Validation Resume Sample
Esther Cormier
358 Lelah Crescent,
Detroit,
MI
+1 (555) 462 9387
Work Experience
QA Validation Specialist
05/2017
-
PRESENT
New York, NY
- Different type of Validation documents (DQ, IOQ,PQ,CV,PV,VMP)
- Consultation of different systems My Learning, SAP, Documentum, Sentry
- Concept of Change Request
- Concept of not conformity
- Validation of Systems and Processes
- Generation and distribution of clean utilities
- Cleaning systems, sterilization and depirogenation concept
- Formulation, Filling, Inspection management
Coordinator QA Validation
06/2013
-
02/2017
Detroit, MI
- To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis, periodic review),
- To review and approve specific qualification and validation documentation (TCD,IQ, OQ, PQ, PV),
- To ensure the adequate review of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority)
- This job is highly specialized in the technical domain of validation but requires also a lot of interaction with numerous partners across the organization and many others quality systems. Therefore it requires a good understanding of the organization and interactions within the company
- Experience in similar roles
- Solid working knowledge of FDA, GMP, ISO and ICH regulations, especially for quality by design and validation topic
- At least 3/5 years of experience on Quality System Management within pharmaceutical field with focus on analytical equipment, computerized system validation and Data Integrity
- Good interpersonal skills, ability to communicate, negotiate and interact constructively with colleagues and other functions, within a matrix context. Strive for results, team working, problem solving and customer orientation attitude
System Test SW QA Validation Engineer Internship
02/2008
-
05/2013
Boston, MA
- GMP archive and management of the documentation
- To define the validation strategies through the change control process (RPC),
- To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
- To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
- To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
- To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority)
- Blow a quality and compliance mindset through the validation activities
- Develop and continuous improve expertises linked with global and corporate expertise functions
Education
Kettering University
2004 - 2008
Engineer's Degree in Chemical Engineering
Professional Skills
- Strong planning and organizational skills and experience managing multiple priorities simultaneously
- Demonstrated risk-based decision making skills
- Strong communication/presentation skills during internal/external audits
- Maintain and administer the change control & validation program and procedures, the validation library and revalidation schedule
- Experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process and cleaning validation
- Create Validation Master Plans and Validation Plans for Manufacturing and Packaging processes
- Experience in progressively responsible job related experience including 2 years in a supervisory role
How to write QA Validation Resume
QA Validation role is responsible for english, french, reporting, training, database, auditing, shipping, planning, manufacturing, design.
To write great resume for qa validation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QA Validation Resume
The section contact information is important in your qa validation resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your QA Validation Resume
The section work experience is an essential part of your qa validation resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous qa validation responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qa validation position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QA Validation resume experience can include:
- 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
- Review and approve all Process, Equipment, Cleaning and Utilities Validation Protocols for compliance to internal Process Validation Program requirements
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s
- Managing the Equipment Validation and Calibration groups consisting of at least four (4) staff
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
Education on a QA Validation Resume
Make sure to make education a priority on your qa validation resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa validation experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in QA Validation Resume
When listing skills on your qa validation resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical qa validation skills:
- Demonstrated ability to manage multiple projects and tasks concurrently and effectively
- Good oral and written communication skills in French & English
- Good Communications skills with team and with client
- Well organized and structured and good social skills
- Good understanding of validation principles as applied to processes, equipment, cleaning and/or facilities
- Prepare and report all Process, Equipment, Cleaning and Utilities Engineering Validation audits through PPR’s, Validation Periodic Reviews, etc
List of Typical Experience For a QA Validation Resume
1
Experience For QA Validation Specialist Resume
- Supporting CQV strategies through the execution of validation and commissioning plans and protocols
- Working knowledge of manufacturing equipment, process, and facility validation in a pharmaceutical or biotech environment
- 2 Assists in achieving validation study objectives/schedules while working across multiple departments
- 1 Rapidly gains knowledge and of cGMPs, pharmaceutical manufacturing methods and validation principles desired
- Good knowledge of pharmaceutical and process engineering
2
Experience For Coordinator QA Validation Resume
- Good understanding of cGMP guidelines applicable for USFDA
- Define the validation strategies through the change control process (eCC)
- Provides QA expertise support to new product introduction projects and related validations
- Develop and continuous improve expertise linked to the primary validation activities
- Responsible for review and approval of validation documentation
- Proven knowledge in Quality Assurance
- Interpret and relate Validation standards for implementation and review to functional areas
- Support improvement of the validation process in general in Dako. (QMS18 and associated TP’s and TX’s.)
3
Experience For QA Validation Engineer Resume
- Support the development of systems specific CQV schedules and execution of related activities, including compilation and reporting of program metrics
- Promote clear communication with Production staff, QA, QC, Engineering and Site Management
- 8 Researches governmental regulatory requirements and industry guidance on assigned projects
- 9 Other tasks as required by Departmental Management
- 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,
4
Experience For QA Validation Manager Resume
- Participate in teams to present Product QA and Process, Equipment, Cleaning and Utilities Engineering Validation documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports
- Review and coordinate Change Controls
- 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
- 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
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
5
Experience For Associate QA Validation Project Manager Resume
- Develop and continuous improve expertise linked to the primary validation activities # expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
- 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, TTS’s, etc.)
- Establish, deploy and execute a validation process which is in line with PMI requirements and predefined procedures
- Determine and deploy change management activities
- Organize and lead verification assessments
6
Experience For Senior Project Leader QA Validation Oversight Resume
- Lead and make sure that product & process quality reviews are regularly performed, management reviews are performed and documented according to predefined procedures
- Establish a system to identify, record and evaluate internal or external solutions to resolve critical deviations. Determine and coordinate potential Product Related Special Situation management
- Deploy and execute a monitoring system to identify changes, procedures, activities through when appropriate historical data and trend analysis to identify potential deviations and preventive actions. Ensure execution and update of monthly, weekly and on demand quality reports
- Gather and manage related intermediate and finished product corrective and preventive actions to continuously improve final product quality and keep records of related actions
- Well-developed PC skills (Microsoft Project, Excel, Word, PowerPoint, Outlook)
7
Experience For Associate, QA Validation Resume
- Experience in Quality Assurance in pharmaceutical, food or similar industry
- Advanced knowledge of relevant standards (ISO, ICH, GMP and GLP)
- Open minded, independent and accurate
- Fluent level of written and spoken English and Dutch
- Project management of calibration activities and equipment validation and/or requalification in accordance with SOPs, master plans, regulatory expectations and industry standards
- Management and oversight of the calibration group and equipment validation/calibration contractors
- Scheduling, planning, managing and following up on validation/calibration activities, projects and deliverables, timelines, new equipment specifications, installation and use, facility/system/process improvement, equipment and systems modifications and additions and requalification
- Timely development and completion of validation protocols and validation summary packages
- Participate in meetings with the client
8
Experience For QA Validation Associate Resume
- Challenge, review and approve qualification and validation (TCD, IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures,
- Ensure both adequate oversight and follow-up on the validation deviations in terms of content,
- Generates, executes, reviews, approves, master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Travels to external sites to support Regeneron related validation activities
- Reviews, edits and approves validation deviations, investigations, and corrective actions
- Trains/advises and/or supervises less experienced Specialists
- Take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP) of a Primary MPU
- Knowledge of cGMPs for biotechnology
- Support of regulatory submissions
9
Experience For System Test SW QA Validation Engineer Internship Resume
- Support for audits and inspections
- QA-Lead in tech transfer
- Follow directions; performs well-defined tasks
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
- Review Change Controls, Incidents, Investigations, CAPAs, SOPs
10
Experience For QA Validation CSV Specialist Resume
- Implementing project quality and compliance oversite through the compliant and effective understanding and application of a quality risk management approach to commissioning, qualification and validation
- Support regulatory submissions and regulatory agency inspections as required
- 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
- Experience in qualification/validation
- Extract requirements and manage large teams
List of Typical Skills For a QA Validation Resume
1
Skills For QA Validation Specialist Resume
- Provide validation guidance/training to internal and external customers and support cross-functional validation efforts for technology transfer, etc
- Strong knowledge of cGMPs and QMS pertaining to validation
- Confident presentation/communication skills – willing to make decisions with support
- Experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process validation
- Experience in Cleaning Validation of biopharmaceutical process equipment
- Act as a validation subject-matter expert to provide consistency in the validation approach for equipment, systems, computers, methods and processes
- Perform and/or support validation activities, and trend, analyze, and interpret data to monitor performance and support revalidation decisions for changes, etc
- Well-developed technical writing and oral communication skills
2
Skills For Coordinator QA Validation Resume
- Superb ability to use collaborative skills to develop rapport with internal stakeholders
- Demonstrated ability to prioritize work and adapt to change
- Professional experience in pharmaceutical environment (with specific validation environment)
- French speaker with written and spoken English skills
- Experience in validation activities
- Work as part of a high performing team and collaborate effectively with staff at all levels
- Reviewing and approval of calibration and/or validation work requests in the equipment management database and change control system
- Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making
3
Skills For QA Validation Engineer Resume
- Good understanding of engineering principles and IQ, OQ, PQ documentation is an asset
- Leads in developing validation strategies for complex and diverse decision-making that could have functional or global impact
- Drafts, reviews, and executes protocols and reports related to equipment, facility, and computer validation. This includes deviation reporting during execution
- Experience in any of the following: Process, Equipment, Computer,
- Apply client’s validation methodology: configuration verification, UAT testing, User functionality, COTS
- Provide guidance to Engineering, Technical and Production partners on validation decisions
- Support during corporate and regulatory inspections for validation related topics
- Write some validation (VP, VSR, Risk Assessment, Gap Analysis, periodic review) documentation according to the GSK Bio standards and procedures,
- Day to day oversight of cleaning validation contract specialists where required
4
Skills For QA Validation Manager Resume
- Write validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Vaccines standards and procedures
- Organization and planning for qualification and validation of equipment, IT Systems and processes
- Documentation and QA oversight during validation
- Process validation- including risk assessments
- GMP-Experience in pharmaceutical industry in engineering, production or quality department
- Read/interpret validation and engineering documents (protocols and reports)
- Validate/qualify production equipment, systems, and processes in accordance with regulatory requirements
- Create, revise and manage validation master plans, protocols and reports
- Perform gap analysis on current validation and remediate as necessary
5
Skills For Associate QA Validation Project Manager Resume
- Supervise conduct of validation activities and advise on course of action for problem resolution
- Sign as document owner on validation & change control documents
- Master the key QA activities related to production, QC, maintenance, calibration, and validation in the area of responsibility
- Possess expert knowledge in equipment validation and calibration and broad knowledge related to quality assurance
- Good overall knowledge of pharmaceutical business operations within scope of job
- Demonstrated proficiency in computer systems
- Knowledge of Solid Dose, Liquids/Topicals product processes is an asset
6
Skills For Senior Project Leader QA Validation Oversight Resume
- Good understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
- Read/interpret validation and engineering documents
- Demonstrated ability to manage multiple activities while maintaining a high level of organization
- The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
7
Skills For Associate, QA Validation Resume
- Level to be determined based upon experience.
- Create and maintain validation templates, SOPs, Master Forms and other essential tools
- Provide project management oversight for validation activities related to BioMarin’s products and facilities, utilities, equipment (FUE), and CSV
- Performs internal audits, shopfloor, gemba’s and effectiveness check
- Understanding of formulation, manufacturing principles and manufacturing and packaging equipment
- Collaborating closely with Manufacturing and Engineering for activities and documentation related to Commissioning and Qualification programs
- Reviewing and approving of CSV specific SOP’s and Templates
8
Skills For QA Validation Associate Resume
- Auditing documentation for compliance
- Shipping / Cold Chain
- Providing project status reports to QA and VCMP management
- Providing relevant reports and metrics both internally and to the client
- Problem solving and achievement oriented, proposals and negotiating ability and belief
9
Skills For System Test SW QA Validation Engineer Internship Resume
- Establish proper archiving of all related data about processes, laboratory, systems and cleaning activities
- Knowledge of current regulatory expectations and industry standards relating to compliance
- Possess a working knowledge of quality systems
- Problem solving and achievement oriented
- Work independently to meet demanding objectives and tight deadlines
- Apply regulatory authority and guidelines with training
- Basic understanding of pharmaceutical laboratory and / or production operations
- Edits Standard Operating Procedures (SOPs), Protocols, and reports independently and accurately
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
10
Skills For QA Validation CSV Specialist Resume
- Assists in customer/regulatory audits and responding to audit observations and corrective actions
- Clinical, Quality and PQR systems
- Manage projects and prepare status reports & schedules for annual PM / Calibrations
- Investigate and troubleshoot problems which occur and determine solutions or coordinate with outside service provider
- Review, edit and approve deviation notifications, deviation investigations, and corrective actions
- Review, edit and approves change controls, SOPs, reports and other documentation
- Create and revise quality system procedures, forms and equipment specifications
- Perform deviation investigations and resolutions through the CAPA system
- Provide direction to vendors
List of Typical Responsibilities For a QA Validation Resume
1
Responsibilities For QA Validation Specialist Resume
- Validation experience on premise and in cloud
- Recommend new ways to approach validation – electronic execution
- Professional experience in pharmaceutical environment
- Strong knowledge of GMP
- Support process hold time data for bulk products as well as develop equipment cleaning parameters (e.g. dirty hold times, campaign parameters, etc.)
- Participation on EI teams
- Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
2
Responsibilities For Coordinator QA Validation Resume
- Conformance to the qualification KPI’s Adherence to project schedule restrictions
- Continuous knowledge development of industry regulations and best practices
- Good interpersonal relationship skills to be a good team player in order to success in each validation project a knowledge of good practices in biopharmaceuticals,
- Methodology – Waterfall, Agile, Scrum, Hybrid
- Risk-base approach: GxPs, GAMP5
3
Responsibilities For QA Validation Engineer Resume
- Concepts: IQ, OQ, PQ for Clinical, Quality and PQR
- Assist team with support
- Learn and use quality management software (e.g. TrackWise®, ComplianceWire®)
- Experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in Facilities, Utilities, Equipment (FUE), Packaging and CSV (Computer Systems Validation) areas
- Reduced-Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes
4
Responsibilities For QA Validation Manager Resume
- +5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation
- Reviews deviation notifications, deviation investigations, and corrective actions
- Reviews change controls, SOPs, reports and other documentation
- Participate on project teams responsible for scale-up, technology transfer, etc
- Conduct and document validation reviews for manufacturing and packaging processes, equipment validation, equipment cleaning processes, and facilities systems. Make recommendations and ensure completion of actions
- Ensure project & documentation compliance with external regulatory (HPFBI, FDA) and QMS requirements
- The function requires
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