Validation Analyst

Axtria - Ingenious Insights; Gurugram District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Axtria - Ingenious Insights is seeking an experienced CSV Validation Specialist to own the Computer System Validation workstream for Vault CRM programs under GxP. You will author validation deliverables and execute IQ/OQ/PQ, ensuring compliance with 21 CFR Part 11 and EU Annex 11.

Work with business SMEs, QA, and client compliance teams, manage deviations, and maintain eQMS documentation to support audit readiness and regulatory inspections.

Qualifications

• 3+ years of hands-on CSV experience on regulated Life Sciences systems (Veeva, SAP, LIMS or similar).
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA).
• Experience authoring and executing IQ/OQ/PQ protocols.
• Understanding of Veeva's pre-validated platform model and the shared-responsibility validation approach.
• Familiarity with eQMS platforms and controlled-document workflows.
• Strong documentation discipline and attention to detail.

Responsibilities

• Own the CSV workstream for Vault CRM programs under GxP.
• Author validation deliverables: Validation Plan, URS, FRS, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Report.
• Execute OQ/PQ scripts on client configurations; document evidence and manage deviations.
• Assess impact of Vault 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 in Vault.
• Support audit readiness and respond to audit queries.
• Maintain validation documentation in an eQMS (Veeva QualityDocs, MasterControl, TrackWise, etc.).

Skills

CSV validation

GAMP 5

21 CFR Part 11

EU Annex 11

ALCOA data integrity

IQ/OQ/PQ protocols

Veeva validated platform

eQMS familiarity

Documentation discipline

Client coordination

Tools

Veeva

SAP

LIMS

Job description

Own the Computer System Validation (CSV) workstream for Vault CRM programs that fall under GxP. Author validation deliverables, execute IQ/OQ/PQ, and ensure the solution meets 21 CFR Part 11, EU Annex 11, and client SOPs. Leverage Veeva's pre-validated platform status where applicable.

Key Responsibilitie

• Develop validation plans aligned with GAMP 5, leveraging Veeva's platform validation evidence where applicabl
• Author validation deliverables: Validation Plan, URS, FRS, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Repor
• Execute OQ/PQ scripts on client-specific configuration and customizations; document evidence and manage deviation
• Assess impact of Vault's periodic releases and author release-qualification evidenc
• Coordinate with business SMEs, QA, and client compliance teams on reviews and approval
• Ensure Part 11 controls: electronic signatures, audit trail, access control are correctly configured in Vaul
• Support audit readiness and respond to internal/external audit querie
• Maintain validation documentation in an eQMS (Veeva QualityDocs, MasterControl, TrackWise, etc.

)
Must-Have Skills & Experien

• 3+ years of hands-on CSV experience on regulated Life Sciences systems (Veeva, SAP, LIMS, or simila
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA
• Experience authoring and executing IQ/OQ/PQ protoco
• Understanding of Veeva's pre-validated platform model and the shared-responsibility validation approa
• Familiarity with eQMS platforms and controlled-document workflo
• Strong documentation discipline and attention to deta

il
Nice-to-H