1. You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets / agencies.
2. You review and approve simple to moderate GMP documentation (Changes, plans, protocols, technical documentation, etc.
related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory and Biogen Quality and Process systems .
3. In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).
4. You work with the senior Quality Engineering Team to identify / revise / develop and implement complex Quality systems that can be global in scope.
5. You ensure adherence to internal procedures for facility / equipment controls and release before, during and after production operations (i.
e. routine operations, shutdowns, construction projects, product changeover, etc.)