A

Validation Analyst

Axtria · Noida, Uttar Pradesh, India

2–6 yrs experiencefull_timePosted 1w ago

Job description

Position Summary 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 Behavioural Competencies - Teamwork Leadership - Motivation to Learn and Grow - Ownership - Cultural Fit Technical Competencies - Problem Solving - Lifescience Knowledge - Communication - Capability Building / Thought Leadership