Qualification & Validation Expert - Computerised System Quality

Sanofi

Val-de-Reuil, France
Onsite
Computerised systems quality
Validation and qualification
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 within your scope of responsibility

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 within your scope of responsibility.
  • You will be the quality representative throughout the Life Cycle of server-based Computerized Systems (e.g., Manufacturing Execution System, Laboratory Information Management System, Distributed Control System, Environment Monitoring Solution, etc.), as well as IT infrastructures (Server rooms, virtualization, databases, backup/restore, etc.), in both project and routine modes.
  • You will benefit from a wide range of health and well-being benefits, including high-quality healthcare, prevention and wellness 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 within your scope of responsibility.

Skills & Requirements

Must-have

  • Computerised Systems Quality
  • Validation and Qualification
  • Regulatory inspections
  • GAMP5
  • BPF/GMP
  • 21 CFR Part 11

Nice-to-have

  • Innovation and proposal
  • Convincing and unifying
  • Cross-functional collaboration

Key Requirements

  • Bac +5, scientific
  • English B2 level
  • Experience in pharmaceutical industry
  • Knowledge of group quality standards
  • Knowledge of main regulations

Work Rights

Not specified

Tailored Resume

Cover Letter