Qa-sme

Ferring India Laboratories

India
Not specified
Csv experience
Us fda 21 cfr part 11
Eu annex 11
Ferring India Laboratories is seeking a Quality Assurance Subject Matter Expert (QA-SME) with extensive experience in computer system validation and regulatory compliance within the pharmaceutical industry. The ideal candidate will have a strong foundation in validation documentation and familiarity with various quality management systems and regulations

Job Summary

  • Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 is required.
  • Strong background in pharma industry validation within GLP/GMP environments is essential.
  • Knowledge of GMP, Data integrity, and digital remediation is also required.

Matching Summary

Match Score: 85

Ferring India Laboratories is seeking a Quality Assurance Subject Matter Expert (QA-SME) with extensive experience in computer system validation and regulatory compliance within the pharmaceutical industry. The ideal candidate will have a strong foundation in validation documentation and familiarity with various quality management systems and regulations.

Skills & Requirements

Must-have

  • CSV experience
  • US FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • Pharma industry validation
  • Develop validation documentation

Nice-to-have

  • Agile Development experience
  • Process Automation knowledge
  • Laboratory Automation knowledge
  • Enterprise IT Applications knowledge
  • Network Infrastructure knowledge

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter