Our Pharmaceutical Diagnostics (PDx) business is the global leader in imaging agents, administered to patients all over the world to improve the images that radiologists use to diagnose and monitor disease. As QP you are responsible for batch certification. You ensure the batch is produced and checked in accordance with legal requirements, quality guidelines, procedures and registered files. You will work in the dynamic environment of radiopharmaceuticals. Essential Responsibilities
- Review of batch documentation and manufacturing process to support the decision to release the product in accordance with all licensing and GMP requirements
- Reviewing and approving deviations, CAPA, Change Control, Complaints and procedures
- Represent QA in various (development and improvement) projects and advise on the adequacy of validation of facilities, equipment and new products / processes, including design strategies
- Supervising and coordinating inspections by external (regulatory) authorities (IGJ), as well as supporting the QA audit function to ensure GMP compliance
- Establish and maintain quality management systems
- Maintaining current knowledge of pharmaceutical legislation and best practices and implementation thereof.