The following activities will be included as part of your role:

• Designing, executing and reporting on PV/Process Performance Qualifications.
• Designing, executing and reporting on validation studies for equipment, systems and processes.
• Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
• Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation
• Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
• Maintaining validation documentation through the validation lifecycle
• Participation in external regulatory inspections
• Support Site Change Control process