We are working with one of the top global healthcare providers as they grow their team in Ireland. Their new facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies. We are looking for a Dosimetry Lab Supervisor to join their team
You will be responsible for supervising the operation of the ebeam sterilisation dosimetry laboratory while also maintaining the effectiveness of the site dosimetry monitoring program in accordance with GLP, GMP and regulatory requirements. Your role will ensure CAPA activities are followed through to completion. Provide direction and technical expertise to dosimetry laboratory personnel and to the site.
Your Key Responsibilities:
1. Provide product and manufacturing support in a cGMP regulatory environment.
2. Supervise, develop, and mentor employees within the team.
3. Develop and drive the site dosimetry program, updating as appropriate.
4. Manage and co-ordinate all the dosimetry lab activities, including coordination with providers and suppliers.
5. Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
6. Write documentation for dosimetry lab methods, equipment qualifications and equipment validation and provide guidance and feedback.
7. Support laboratory set-up and maintenance of laboratory equipment and consumables.
8. Drive the laboratory training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
9. Review laboratory results, to ensure accuracy of data and timely communication of results.
10. Ensure dosimetry lab is validated and controlled and comply with internal requirements, applicable regulations and ISO11137 standards.
11. Provide technical guidance and support, in the areas of dosimetric release methods, dose mapping procedures and dosimetry curve calibration.
12. Lead problem solving efforts related to dosimetric release and provide technical advice as required.
13. Support unplanned events and raise out of specification results in a timely manner.
14. Initiate and complete CAPAs and Change Controls in accordance with site procedures.
15. Analyse product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Generate and present quarterly and annual reports.
16. Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
What We're Looking For:
17. Third level Science / Manufacturing or equivalent qualification.
18. Minimum four years' work experience in a Manufacturing / Science / Quality or equivalent environment.
19. Electron beam or other sterilisation technologies experience desirable.
20. Knowledge in ISO 11137 desirable.
21. Chemistry/Microbiology/Dosimetry Lab experience desirable.