As QMS Expert your main responsibility is to serve as site liaison to global functions for documentation, training and corporate quality systems e.g. change control, CAPA and exception management. You will be the quality point of contact for project managers and ensure quality commitments are delivered on time.
- Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in the site.
- Design, review and maintain Site Master File for the site to ensure site GMP readiness as per project timeline.
- Represent the site's Quality within the global quality organization to ensure local implementation of the global QMS. This includes review and approval of electronic log books.
- Responsible for managing the Quality Risk Register and ensure appropriate risk assessments are in place.
- Bachelor or Master degree in Life Science preferred.
- Approximately 10 years of experience in pharmaceutical or biotech manufacturing environment.
- Prior experience with fully electronic operations and management is preferred.