Develop validation plans aligned with GAMP 5, leveraging Veeva's platform validation evidence where applicable
Author validation deliverables: Validation Plan, URS, FRS, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Report
Execute OQ/PQ scripts on client-specific configuration and customizations; document evidence and manage deviations
Assess impact of Vault's periodic releases and author release-qualification evidence
Coordinate with business SMEs, QA, and client compliance teams on reviews and approvals
Ensure Part 11 controls: electronic signatures, audit trail, access control are correctly configured in Vault
Support audit readiness and respond to internal/external audit queries
Maintain validation documentation in an eQMS (Veeva QualityDocs, MasterControl, TrackWise, etc.)
