Validation Analyst

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