Qualification & Validation Expert - Computerised Systems Quality

Sanofi UK

Val-de-Reuil, France
Onsite
Computerised systems validation
Quality assurance
Regulatory inspections
You will be responsible for 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 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.
  • 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.).
  • Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and create long-term growth.

Matching Summary

You will be responsible for 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
  • GAMP5
  • BPF / GMP
  • 21 CFR Part 11

Nice-to-have

  • Client and results oriented
  • Innovative and proactive
  • Ability to convince and federate
  • Cross-functional collaboration

Key Requirements

  • Bac +5, scientific
  • Pharmaceutical industry experience
  • Quality/Compliance experience
  • Knowledge of group quality standards
  • Knowledge of current regulations
  • English B2 level

Work Rights

Not specified

Tailored Resume

Cover Letter