CSV Consultant
A leading pharmaceutical/biotech organisation is seeking an experienced Computer System Validation (CSV) Consultant to support critical projects in compliance with GAMP 5 guidelines. This role offers the opportunity to contribute to high-impact initiatives within a regulated environment, ensuring systems meet stringent quality and compliance standards.
Key Responsibilities
- Lead and execute CSV activities in alignment with GAMP 5 and regulatory requirements
- Develop, review, and approve validation documentation (URS, FS, DS, IQ, OQ, PQ, traceability matrices)
- Partner with QA, IT, and business stakeholders to ensure compliance and audit readiness
- Support system lifecycle management, including risk assessments and change control
- Provide expertise during regulatory inspections and internal audits
Requirements
- Minimum 5 years' experience in Computer System Validation within pharma/biotech
- Strong knowledge of GAMP 5 and EU GMP Annex 11/21 CFR Part 11 compliance
- Proven track record of delivering CSV projects in regulated environments
- Excellent communication and stakeholder management skills
- Ability to work on-site in France or the Netherlands
What's on Offer
- 12-month freelance contract with competitive day rate
- Opportunity for permanent employment for the right candidate
- Work on-site with a global leader in the life sciences sector
- Collaborative, international environment with high visibility projects
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