Assureur Qualité Systèmes Informatisés (aq Vsi / Csv)

Groupe Lfb

Arras, France
Computerized systems validation
Data integrity requirements
Regulatory compliance bpf/gmp
Ensure compliance of computerized systems with regulatory requirements (GMP, 21 CFR Part 11) and actively participate in data and process security

Job Summary

  • Ensure compliance of computerized systems with regulatory requirements (GMP, 21 CFR Part 11) and actively participate in data and process security.
  • Support validation of IT systems for Production and Laboratory, as well as IT infrastructure for the industrial IT team.
  • Benefits include teleworking agreement, transport cost participation, group benefits (health insurance, provident fund, works council), and restaurant tickets.

Matching Summary

Ensure compliance of computerized systems with regulatory requirements (GMP, 21 CFR Part 11) and actively participate in data and process security.

Skills & Requirements

Must-have

  • Computerized systems validation
  • Data Integrity requirements
  • Regulatory compliance BPF/GMP
  • Risk analysis and mitigation
  • Audit trail and access review

Nice-to-have

  • Autonomy and initiative
  • Strong interpersonal skills
  • Structured and organized approach

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter