Qualification & Validation Expert - Computerised System Quality

Sanofi

Val-de-Reuil, Eure, France
Onsite
Validation and qualification activities
Computerised systems quality
Regulatory inspection readiness
As a Qualification & Validation Expert - Computerised Systems Quality, you will be responsible for quality validation and qualification activities for existing and new computerised systems at the VAL-DE-REUIL vaccine manufacturing site

Job Summary

  • As a Qualification & Validation Expert - Computerised Systems Quality, you will be responsible for quality validation and qualification activities for existing and new computerised systems at the VAL-DE-REUIL vaccine manufacturing site.
  • Sanofi offers a supportive and forward-looking team environment, opportunities for career development including promotions and internal mobility, and a wide range of health and well-being benefits including at least 14 weeks parental leave regardless of gender.
  • You will represent the quality function throughout the lifecycle of computerised systems, ensure compliance with Sanofi quality procedures and standards, and act as a subject matter expert during audits and inspections by health authorities.

Matching Summary

As a Qualification & Validation Expert - Computerised Systems Quality, you will be responsible for quality validation and qualification activities for existing and new computerised systems at the VAL-DE-REUIL vaccine manufacturing site.

Skills & Requirements

Must-have

  • Validation and qualification activities
  • Computerised systems quality
  • Regulatory inspection readiness
  • GAMP5 and GMP compliance
  • Cross-functional collaboration
  • Quality event reporting

Nice-to-have

  • Innovation and proposal skills
  • Client and results orientation
  • Ability to convince and federate
  • Work in transversal teams

Key Requirements

  • Experience in pharmaceutical industry quality or production
  • Knowledge of GAMP5, GMP/BPF, 21CFR Part 11
  • Bachelor's degree plus 5 years in scientific field
  • English language proficiency at B2 level

Work Rights

Not specified

Tailored Resume

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