Senior Associate/ Project Leader- Validation Analyst

Job description

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 • Strong 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