validation lifecycle. Review validation documentation including Validation Plans, Validation Reports, requirements, traceability matrices, design documentation, test plans, test reports, testing records, defects, and data migration documentation. Identify, document and escalate GxP compliance risks and support appropriate risk mitigation, deviations and CAPAs. Provide QA oversight of change controls … electronic systems, ensuring changes are appropriately assessed, documented, approved and validated. Interpret and apply regulatory requirements relating to Computer System Validation, Data Integrity, Electronic Records and Electronic Signatures, including 21 CFR Part 11. Support regulatory inspections, third-party inspections and internal audits while ensuring systems and documentation remain ...