San Francisco, California
•
3d ago
Responsibilities: Lead Computer System Validation (CSV) activities, including plans, protocols (IQ/OQ/PQ), reports, SOPs, and risk assessments.Collaborate with business, IT, and compliance teams to define and execute validation requirements.Provide oversight, training, and leadership for validation processes across regulated environments.Ensure compliance with FDA, EU GMP, 21 CFR Part 11, Annex 11, and other standards.Manage audits, deviations, CAPAs, and change controls.Act as SME for CSV, driv
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Contract
Depends on Experience

















