Role Summary

Own the Computer System Validation (CSV) workstream for Vault CRM programs that fall under GxP. Author validation deliverables, execute IQ/OQ/PQ, and ensure the solution meets 21 CFR Part 11, EU Annex 11, and client SOPs. Leverage Veeva's pre-validated platform status where applicable.

Key Responsibilities

• 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.)

Must-Have Skills & Experience

• 3+ years of hands-on CSV experience on regulated Life Sciences systems (Veeva, SAP, LIMS, or similar)

• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+)

• Experience authoring and executing IQ/OQ/PQ protocols

• Understanding of Veeva's pre-validated platform model and the shared-responsibility validation approach

• Familiarity with eQMS platforms and controlled-document workflows • Robust documentation discipline and attention to detail

Nice-to-Have

• Direct experience validating Veeva Vault (CRM, QualityDocs, QMS, or CTMS)

• ISPE GAMP certification

• Exposure to computerized systA13:B37

📌 Senior Associate/ Project Leader Validation Analyst Maharashtra
🏢 Axtria
📍 Maharashtra