Validation Analyst (Noida)

Validation Analyst (Noida)

22 Oct
|
Axtria - Ingenious Insights
|
Noida

22 Oct

Axtria - Ingenious Insights

Noida

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

📌 Validation Analyst (Noida)
🏢 Axtria - Ingenious Insights
📍 Noida

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