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