Qualification & Validation Expert - Computerised Systems Quality
Sanofi UK
Val-de-Reuil, Eure, France
Base: €42,400.00 - €56,533; bonus/equity: not spec...
Onsite
Gamp5 knowledge required
21 cfr part 11 compliance
Manufacturing execution system experience
This role involves being the quality representative for the lifecycle of computerized systems including MES, LIMS, and DCS
Job Summary
This role involves being the quality representative for the lifecycle of computerized systems including MES, LIMS, and DCS.
The expert is 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
This role involves being the quality representative for the lifecycle of computerized systems including MES, LIMS, and DCS.
Salary
Base: €42,400.00 - €56,533; Bonus/Equity: Not specified; Benefits: Health care, wellness programs, parental leave
Skills & Requirements
Must-have
GAMP5 knowledge required
21 CFR Part 11 compliance
Manufacturing Execution System experience
Regulatory inspection representation
Validation strategy approval
Nice-to-have
Strong cross-functional collaboration
Innovation and problem-solving skills
Fluent English communication
Leadership in quality initiatives
Key Requirements
Bachelor's degree plus 5 years (Bac +5)
Experience in pharmaceutical industry quality or production