About the role

This role involves ensuring compliance with cGMP standards through the validation of computerized systems. You will be responsible for developing and executing validation studies, generating documentation, and maintaining the validated status of systems.

This position requires hands-on involvement and technical expertise in validation processes. Ideally, you have experience in the pharmaceutical sector and a strong understanding of quality and compliance regulations

Key responsibilities

• Develop, implement, and execute validation studies for cGMP-critical computerized systems, regarding URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
• Generate validation documentation and assist with protocol execution for computerized systems
• Ensure validated status of systems complies with cGMP standards at all times
• Manage projects in accordance with Sanofi and cGMP regulatory standards
• Provide technical assistance on US FDA and EU validation requirements
  
  

About you

• Strong communication skills for effective collaboration and reporting
• Ability to work independently and adapt quickly to new challenges
• Competent knowledge of Computer Systems Validation processes
• Full understanding of relevant quality and compliance regulations
• Minimum of 3 years of experience in the pharmaceutical sector and GMP environment