Are you a GxP validation professional with hands-on Veeva Vault experience? We're looking for a detail-oriented Validation Analyst to join a high-impact Life Sciences engagement with one of the world's leading technology companies.
What You'll Be Doing :
- Author, execute, and review IQ, OQ, and PQ protocols for Veeva eQMS, CAPA and QRM modules
- Design and maintain GxP-compliant test scripts for functional, integration, and regression testing
- Build and manage Requirements Traceability Matrices (RTMs) and Validation Summary Reports
- Conduct Functional Requirements Risk Assessments with Business Owners and Quality teams
- Identify, document, and track defects through resolution using tools like qTest / ALM
- Ensure compliance with GAMP5, 21 CFR Part 11, EU Annex 11, and other international regulatory guidelines
- Support USFDA, EMA, and internal regulatory audits with audit-ready documentation
- Collaborate cross-functionally with Business Owners, System Owners, IT, and Quality teams
- Participate in Agile/Scrum sprints and contribute to PI planning activities
What We're Looking For :
- Handson experience with Veeva Vault QMS - QualityDocs, eQMS, CAPA or QRM module
- Proficiency in qTest, Vera, Tosca, or ALM for test case management
- Strong working knowledge of GxP, GMP, GDP, 21 CFR Part 11, GAMP5
- Experience authoring URS, FRS, IQ/OQ/PQ protocols, RTMs, and Validation Summary Reports
- Exposure to USFDA, EMA, ISO, or PMDA regulatory audits
- Familiarity with Agile / SAFe delivery methodology
- Strong documentation and communication skills
What's on Offer :
- Engagement with a global Fortune 500 technology client in the Life Sciences space
- Work on cutting-edge Veeva platform implementations across pharma and biotech clients
- Collaborative, audit-ready team culture with exposure to multi-regulatory environments
- Competitive compensation and career growth opportunities
- Pan India locations - flexible across major delivery centres
Who Should Apply :
If you have been a Validation Engineer, CSV Analyst, QA Validation Specialist, or eQMS Tester in a pharma or biotech setting and are looking to work on enterprise-scale Veeva implementations this role is built for you.
(ref:hirist.tech)AppsTek Corp - Veeva eQMS Tester/Validation Analyst • Chennai