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).
Job 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.)
Education
Bachelor of Engineering
Master of Computer Application in Information Technology or Computer
Work Experience
0-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company Business Operation & Technology