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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in QA support for validation and qualification processes in a GMP-regulated environment, with a strong focus on equipment qualification, automation, and compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11.
Highest-signal resume keywords
GMP ComplianceValidation DocumentationComputer System Validation (CSV)Quality Risk ManagementFMEA
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Equipment QualificationAutomation ValidationTechnical Change ControlRisk AssessmentData Integrity
Soft Skills
CollaborationDocumentation ReviewChallenge Risk Assessments
Certifications & Qualifications
Relevant BSc or MSc Degree
Industry Keywords
GMP21 CFR Part 11EU Annex 11Device ActivitiesCombination-Product Activities
About the role
Key responsibilities & impact- Provide QA support and oversight for validation and qualification of equipment, automation, processes and information systems
- Review and approve validation and qualification documentation for GMP, regulatory, corporate and site compliance
- Define and challenge validation strategies with Engineering, Manufacturing, Product Development and Information Systems
- Provide QA guidance during design, characterization, commissioning, qualification and validation
- Support CSV and computer system compliance
- Review protocols, reports, risk assessments and technical documentation
- Review and approve technical changes to equipment and engineering procedures
- Apply a risk-based approach to technical and engineering changes
- Provide QA oversight for device and combination-product activities
- Act as QA representative in Quality Risk Management activities
- Facilitate or contribute to FMEA, risk assessments and equipment/automation criticality assessments
- Perform final QA review of technical change controls and coordinate relevant QA input
- Assess changes for impact on validation, GMP, data integrity and compliance
Requirements
What you’ll need- Relevant BSc or MSc degree
- Approximately 5–7 years of professional experience in a GMP-regulated environment
- Strong background in GMP, equipment qualification, automation and validation
- Experience in C&Q, QA review, CSV, data integrity, FMEA, validation documentation and technical change control
- Understanding of qualification and validation of equipment, automation and computerized systems
- Ability to review documentation, challenge risk assessments, support change controls and work with multidisciplinary project teams
- Knowledge of GMP, 21 CFR Part 11, EU Annex 11 and data integrity requirements
- Experience with device and combination-product activities
- Experience with quality risk management, FMEA, risk assessments and equipment/automation criticality assessments
Benefits
Comp & perks- Make a real impact by supporting innovative projects and clients across pharma, biotech and medical devices
- Knowledge-sharing and mentoring
- Exposure to diverse, challenging assignments
- Tailored, transparent compensation aligned with expertise, preferences, and local market regulations
- Meaningful career development within the life sciences industry
- Joining a community of 500+ experts across 8 countries