Our Pharmaceutical Diagnostics (PDx) business is a global leader in imaging agents, used to improve and enhance the images that radiologists use to diagnose and monitor disease. We support healthcare professionals in the administration of neurology, cardiology and oncology procedures that are used to image three patients around the world, every second.
GE Healthcare in Eindhoven manufactures radiopharmaceutical products and distributes this to hospitals worldwide. As Sterility Assurance Expert, you are the outspoken expert of the production site on Sterility Assurance related topics. You own the sterility assurance program that must stay compliant to GMP guidelines. You also lead the microbiology department which is responsible for QC testing. Essential Responsibilities:
- Giving direction to the production site in developing and maintaining the required Sterility Assurance Level
- Giving advice to the manufacturing and QA departments in the areas of cleanroom operations and aseptic working by participating in projects and investigations
- Leading the implementation of the new GMP Annex 1 guidelines including the Contamination Control Strategy and other improvement initiatives
- Participating in audits as an expert / lead in the field of Sterility Assurance and carrying out internal and external supplier audits
- Identifying possible quality risks regarding product sterility and contributing to solutions to mitigate the risks to an acceptable level
- Managing, motivating, guiding and coaching the people in your QC Microbiology team of 4 (senior) analysts.