Our client is seeking a Production expert from a steriles/ aseptic background who will be able to provide resolution of issues and impact assessments for aseptically manufactured and sterilized products which are related to production activities such as deviation impact assessment, assembly, cleaning, processing, full batch review and compliance to module 3 regulatory dossiers.
This is a stand alone role that will provide support to the batch release team in a virtual manufacturing environment, as well as Supplier/ Vendor Quality auditing, ensuring batch releases are compliant with the Marketing Authorisation (MAA) and the Manufacturing Importers Authorisation (MIA) and ensuring Quality Systems within batch release are compliant.
- Experience working in a sterile GXP production environment
- Significant cGMP knowledge
- MHRA/ EMEA inspection experience – FDA would be beneficial as well.
- Knowledge of Quality Systems in a batch release manufacturing environment.