To be a driven business analyst who can work on complex Analytical problems and help the customer in better business decision making especially in Pharma (domain).
| • 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.) |
0-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company Business Operation & Technology
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