Assureur Qualité Systèmes Informatisés (aq Vsi / Csv)

Lfb Usa

Arras, France
Computerized systems validation
Data integrity requirements
Regulatory compliance (bpf/gmp, 21 cfr part 11)
You will be responsible for the compliance of systems with regulatory requirements (GMP, 21 CFR Part 11, Annexes 11, 15 and 22) and actively participate in securing data and processes

Job Summary

  • You will be responsible for the compliance of systems with regulatory requirements (GMP, 21 CFR Part 11, Annexes 11, 15 and 22) and actively participate in securing data and processes.
  • Your missions will include approving validation strategies and plans, supporting the drafting of technical stops and periodic reviews, and contributing to business solutions related to computerized systems.
  • Benefits include a teleworking agreement of up to 2 days per week, transport cost participation, and group advantages such as health insurance, provident fund, works council, and nursery places.

Matching Summary

You will be responsible for the compliance of systems with regulatory requirements (GMP, 21 CFR Part 11, Annexes 11, 15 and 22) and actively participate in securing data and processes.

Skills & Requirements

Must-have

  • Computerized systems validation
  • Data Integrity requirements
  • Regulatory compliance (BPF/GMP, 21 CFR Part 11)
  • Risk analysis and mitigation
  • Support validation teams

Nice-to-have

  • Autonomy and organization
  • Good interpersonal skills
  • Rigorous and structured approach

Key Requirements

  • 3 years minimum experience
  • Bac+5 degree in IT, engineering, or quality
  • Experience in pharmaceutical industry
  • Proficiency in GAMP 5, Annex 11, 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter