The Regulatory and Validation Department located in Puurs is seeking a dynamic Validation and Regulatory Quality Associate to join our team..
In this role you will be responsible for validation and product registration activities of the assigned products.
You will work in cross-functional teams with different Puurs departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site.
Are you seeking to work with innovative products, in an exciting and fast evolving environment? Join theteam!
You 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:
- You 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 support regulatory submissions of the 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 Pfizer colleagues and R&D.
- You coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.