QA Analyst – eTMF / GxP / 21 CFR Part 11

6 - 10 years

5 - 9 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Job Overview

We are seeking experienced QA Analysts with expertise in eTMF system implementation, GxP compliance, 21 CFR Part 11, and ICH-GCP. The role involves validation, compliance testing, documentation review, and supporting regulatory requirements across clinical and quality systems.

This is a Chennai-based onsite role, suitable for candidates with strong experience in regulated environments.

Key Responsibilities

  • Lead and participate in eTMF system implementation and validation activities.
  • Ensure systems comply with GxP, 21 CFR Part 11, ICH-GCP, and audit requirements.
  • Perform validation, functional testing, and compliance reviews for clinical applications.
  • Review SOPs, validation deliverables, test scripts, and documentation.
  • Support system readiness for inspections and regulatory audits.
  • Collaborate with QA, IT, and clinical teams to implement quality processes.
  • Maintain documentation aligned with compliance and quality frameworks.

Primary Skills (Must Be Included in Resume)

  • eTMF System Implementation (Veeva, Wingspan, ArisGlobal, etc.)
  • GxP Compliance
  • 21 CFR Part 11
  • ICH-GCP Knowledge
  • CSV Computer System Validation
  • Validation Documentation (URS, FRS, IQ/OQ/PQ, Test Scripts)
  • Audit/Inspection Support
  • Clinical System QA

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