Qualification & Validation Expert - Computerised System Quality

Sanofi UK

Val-de-Reuil, France
Base: €42,400.00 - €56,533; bonus/equity: not spec...
Onsite
Gamp5 knowledge required
21 cfr part 11 compliance
Gmp/bpf regulatory standards
The role involves acting as the quality representative for the lifecycle of server-based computerized systems including MES, LIMS, and DCS

Job Summary

  • The role involves acting as the quality representative for the lifecycle of server-based computerized systems including MES, LIMS, and DCS.
  • Candidates will be responsible for approving validation strategies, test plans, and reports to ensure successful regulatory inspections by authorities like ANSM and FDA.
  • Sanofi offers a comprehensive benefits package including high-quality healthcare, wellness programs, and at least 14 weeks of parental leave.

Matching Summary

The role involves acting as the quality representative for the lifecycle of server-based computerized systems including MES, LIMS, and DCS.

Salary

Base: €42,400.00 - €56,533; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs

Skills & Requirements

Must-have

  • GAMP5 knowledge required
  • 21 CFR Part 11 compliance
  • GMP/BPF regulatory standards
  • Server system lifecycle management
  • Validation strategy approval

Nice-to-have

  • Cross-functional collaboration skills
  • Innovation and problem solving
  • Stakeholder persuasion abilities
  • Project mode experience preferred

Key Requirements

  • Bac+5 scientific degree
  • Experience in pharmaceutical industry
  • Knowledge of GAMP5 and GMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter