Qa-sme

Ferring

India
Us fda 21 cfr part 11
Eu annex 11
Gamp 5
Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, GAMP 5

Job Summary

  • Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, GAMP 5.
  • Strong background in pharma industry validation (GLP/GMP environments).
  • Ability to develop validation documentation: plans, specifications, test protocols, SOPs.

Matching Summary

Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, GAMP 5.

Skills & Requirements

Must-have

  • US FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • pharma industry validation
  • Process Automation
  • Laboratory Automation
  • Enterprise IT Applications
  • Network Infrastructure
  • GMP
  • Data integrity

Nice-to-have

  • Agile Development experience
  • digital remediation

Key Requirements

  • Experience with CSV
  • Experience with US FDA 21 CFR Part 11
  • Experience with EU Annex 11
  • Experience with GAMP 5
  • Experience with pharma industry validation
  • Experience with GLP/GMP environments
  • Experience with V-Model
  • Experience with SDLC Lifecycle
  • Experience with SOPs
  • Experience with SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, FRA/FEMA
  • Experience with QMS tools
  • Experience with Regulatory Audits
  • Knowledge about GMP
  • Knowledge about Data integrity
  • Knowledge about digital remediation

Work Rights

Not specified

Tailored Resume

Cover Letter