Required Skills: Computer System Validation, CSV, GxP-regulated environments, retro-validation and 21 CFR remediation, CSA, GAMP 5, 21 CFR Part 11, Annex 11, FDA/global regulated environments, Validation Plans, Requirements, Test Protocols, Test Summary Reports, Validation Reports, UAT/System Testing scripts, Traceability Matrices, Design Specifications, QA, testing, validation, compliance

Job Description

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments
• Strong experience with retro-validation and 21 CFR remediation projects
• Strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness
• Experience in Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries
• Experience with FDA/global regulated environments and risk-based validation
• Hands-on experience creating and executing Validation Plans, Requirements, Test Protocols, Test Summary Reports, and Validation Reports
• Experience reviewing UAT/System Testing scripts, Traceability Matrices, and Design Specifications
• Strong QA, testing, validation, and compliance experience.
• Ability to lead validation activities, work with remote teams, and manage multiple projects
• Excellent communication, documentation, and stakeholder management skills