Validation Analyst

Axtria - Ingenious Insights; Dadri; On-site; INR 600,000 - 900,000; Full time

Job summary

Axtria - Ingenious Insights in India seeks a driven business analyst who can work on complex analytical problems and help the customer in better business decision making, especially in Pharma (domain).

You will develop validation plans aligned with GAMP 5, author validation deliverables, and execute OQ/PQ scripts across client configurations while ensuring compliant controls and audit readiness. Collaboration with SMEs, QA, and client teams is essential.

Qualifications

• Bachelor of Engineering is required.
• Master of Computer Application in Information Technology or Computer is required.
• 0-5 years of relevant experience in IT services/Consulting/Analytics is expected.

Responsibilities

• Develop validation plans aligned with GAMP 5, leveraging Vault 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.)

Skills

Problem Solving

Lifescience Knowledge

Communication

Capability Building

Teamwork

Leadership

Education

Bachelor of Engineering

Master of Computer Application in IT or Computer

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).

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