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