Novasep is one of the leading CDMOs serving the life sciences and chemical industries. The company offers a wide range of services: development of processes, equipment and molecule purification systems, as well as manufacturing services. For more information: http://www.novasep.com
Novasep Belgium is one of the world leaders in the production of viral vectors. Located in Seneffe and Gosselies, its two sites offer a stimulating and friendly working environment. Novasep Belgium has nearly 250 employees and is currently implementing an ambitious and structured growth plan.
In order to support the development of Novasep Belgium, we are looking for a (m/f) :
Sterility Assurance Specialist
In compliance with any applicable regulations, you drive Novasep sterility assurance programme by defining and ensuring implementation of sterility assurance policy across sites and leading sterility assurance education policy.
Your responsibilities include :
- Sterility Assurance policy and process
- To drive sterility assurance process, defining, harmonizing and ensuring effective implementation of sterility assurance policy
- To develop and maintain related procedures, instructions or any other supporting documentation
- To lead and coordinate aseptic processing simulations.
- To monitor and periodically report on performance of sterility assurance process
- To continually look for improvements of aseptic practices, ensuring proper implementation
- Sterility Assurance education, compliance, validation
- To develop, maintain and continuously upgrade education/training policy, modules and documents
- To pro-actively identify and address possible compliance gaps, proposing, leading or coordinating related corrective and preventative actions (CAPAs)
- To manage deviations, changes controls, CAPA, etc… related to sterility assurance
- To participate to audits
- You hold a scientific or technical diploma.
- You have at least 5-year experience in pharma aseptic manufacturing environment.
- You have a strong knowledge of aseptic processes, sterility concept and supporting microbiological notions.
- You have an in-depth knowledge and understanding of FDA, EMA GMP and ISO requirements pertaining to cleanrooms and aseptic manufacturing.
- You have experience in regulatory inspections including FDA.
- You are recognized for your rigor, organization and planning skills and ability to solve problems.
- You are fluent French and English.
- A diversified function with many responsibilities.
- The opportunity to join a world leader, recognized for its expertise.
- Working in a friendly environment with passionate and motivated colleagues.
- A full-time, permanent contract with a salary package adapted to your profile and level of experience.