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 Responsibilitie s• Develop validation plans aligned with GAMP 5, leveraging Veeva's platform validation evidence where applicabl e• Author validation deliverables: Validation Plan, URS, FRS, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Repor t• Execute OQ/PQ scripts on client-specific configuration and customizations; document evidence and manage deviation s• Assess impact of Vault's periodic releases and author release-qualification evidenc e• Coordinate with business SMEs, QA, and client compliance teams on reviews and approval s• Ensure Part 11 controls: electronic signatures, audit trail,



access control are correctly configured in Vaul t• Support audit readiness and respond to internal/external audit querie s• Maintain validation documentation in an eQMS (Veeva QualityDocs, MasterControl, TrackWise, etc. )

Must-Have Skills & Experien ce• 3+ years of hands-on CSV experience on regulated Life Sciences systems (Veeva, SAP, LIMS, or simila r)• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA

+)• Experience authoring and executing IQ/OQ/PQ protoco ls• Understanding of Veeva's pre-validated platform model and the shared-responsibility validation approa ch• Familiarity with eQMS platforms and controlled-document workflo ws• Solid documentation discipline and attention to deta il

Nice-to-H ave• Direct experience validating Veeva Vault (CRM, QualityDocs, QMS, or CT

MS)• ISPE GAMP certificat ion• Exposure to computerized systA13:

B37

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