This job opportunity focuses on the validation of computerised systems, ensuring they meet required standards and regulations.
Key Responsibilities
* Develop and execute protocols for validating new equipment and control systems.
* Create comprehensive documentation to support validation processes.
* Collaborate with teams to implement change control procedures and provide expert advice on CSV issues.
* Conduct hands-on activities related to DQ, IQ, OQ, and PQ tasks.
* Ensure compliance with Sanofi's and regulatory requirements (Health & Safety, cGMP, construction, environmental etc).
The ideal candidate will possess experience in a healthcare manufacturing environment, preferably within the pharmaceutical sector. They should also be familiar with US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
Requirements
* Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
* Minimum 3-5 years of experience in a healthcare manufacturing setting, ideally in the pharmaceutical sector.
* At least 2-3 years of experience in a validation environment.