Qualification & Validation Expert - Computerised Systems Quality

Sanofi

Val-de-Reuil, France
Onsite
Computerised systems validation
Quality assurance
Regulatory inspections
You will be responsible for the Quality activities of Validation & Qualification for existing and new computerized systems, enabling the company to successfully pass regulatory inspections and contributing to improvements and standardization of Validation & Qualification processes

Job Summary

  • You will be responsible for the Quality activities of Validation & Qualification for existing and new computerized systems, enabling the company to successfully pass regulatory inspections and contributing to improvements and standardization of Validation & Qualification processes.
  • Be the quality representative throughout the lifecycle of server-based computerized systems and IT infrastructures, whether in project mode or routine mode.
  • Take good care of yourself and your family by benefiting from a wide range of health and well-being benefits, including high-quality healthcare, prevention and well-being programs, and parental leave of at least 14 weeks, regardless of gender.

Matching Summary

You will be responsible for the Quality activities of Validation & Qualification for existing and new computerized systems, enabling the company to successfully pass regulatory inspections and contributing to improvements and standardization of Validation & Qualification processes.

Skills & Requirements

Must-have

  • Computerised Systems Validation
  • Quality Assurance
  • Regulatory Inspections
  • Manufacturing Execution System
  • Laboratory Information Management System
  • Distributed Control System

Nice-to-have

  • Client and results orientation
  • Innovation and proposal strength
  • Ability to convince and federate
  • Cross-functional collaboration

Key Requirements

  • Bac +5, scientific
  • Pharmaceutical industry experience
  • GAMP5 knowledge
  • BPF / GMP knowledge
  • 21 CFR Part 11 knowledge
  • English B2 level

Work Rights

Not specified

Tailored Resume

Cover Letter