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
📍 Noida