Ensure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations (GMP, ICH, ..) and with the description in the submitted registration dossiers.
To accomplish the above:
- Perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations. In this quality authority role you will work closely together with different project teams and different departments as well as with R&D
- Support new and/or ongoing regulatory submission of products by informing site colleagues of regulatory requirements and by providing the project details and the supporting validation data to GCMC. In this regulatory role you work closely together with global regulatory colleagues and R&D
- Coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues