Qa-sme

ferring.fr

Ferring India Laboratories
Not specified (assumed to be either hybrid or onsite based on the nature of the role in a laboratory environment).
Experience with csv
Us fda 21 cfr part 11
Eu annex 11
Ferring India Laboratories is seeking a QA Subject Matter Expert (SME) with extensive experience in Computer System Validation (CSV) and the pharmaceutical industry. The ideal candidate will have a strong background in validation documentation and familiarity with regulatory requirements, particularly in GLP/GMP environments

Job Summary

  • Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 is required.
  • A strong background in pharma industry validation within GLP/GMP environments is essential.
  • Ability to develop validation documentation including plans, specifications, test protocols, and SOPs is a key responsibility.

Matching Summary

Match Score: 85

Ferring India Laboratories is seeking a QA Subject Matter Expert (SME) with extensive experience in Computer System Validation (CSV) and the pharmaceutical industry. The ideal candidate will have a strong background in validation documentation and familiarity with regulatory requirements, particularly in GLP/GMP environments.

Skills & Requirements

Must-have

  • Experience with CSV
  • US FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • Pharma industry validation (GLP/GMP)
  • Develop validation documentation
  • Knowledge of V-Model, SDLC Lifecycle

Nice-to-have

  • Agile Development experience
  • Knowledge about GMP, Data integrity, digital remediation

Key Requirements

  • Experience with CSV
  • US FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • GLP/GMP environments
  • V-Model, SDLC Lifecycle
  • SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, FRA/FEMA

Work Rights

Not specified

Tailored Resume

Cover Letter