Your task will be to make sure 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 this:
- You will 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 within Pfizer Puurs as well as with R&D.
- You will support regulatory submission of the new products by informing site members 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 Pfizer members and R&D.
- You will coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management members.