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APPSTEK INFORMATION SERVICES PRIVATE LIMITED
AppsTek Corp - Veeva eQMS Tester/Validation AnalystAPPSTEK INFORMATION SERVICES PRIVATE LIMITED • Chennai
AppsTek Corp - Veeva eQMS Tester/Validation Analyst

AppsTek Corp - Veeva eQMS Tester/Validation Analyst

APPSTEK INFORMATION SERVICES PRIVATE LIMITED • Chennai
30+ days ago
Job description

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 :


- 4+ years of experience in Computer System Validation (CSV) in a pharma / biotech / life sciences environment

- 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)
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AppsTek Corp - Veeva eQMS Tester/Validation Analyst • Chennai