Dosimetry Lab Supervisor
We are partnering with a leading global healthcare provider as they expand their team in Ireland. Their new facility will serve as a centre for world-class engineering, quality, medical device manufacturing, and science-based professionals to develop life-changing technologies.
Key Responsibilities:
* Provide product and manufacturing support within a cGMP regulatory environment.
* Supervise, develop, and mentor employees within the team.
* Develop and drive the site dosimetry program, ensuring updates as necessary.
* Manage and coordinate all dosimetry lab activities, including coordination with providers and suppliers.
* Ensure all work carried out complies with required regulatory standards, company policies, and standard operating procedures (SOPs).
* Write documentation for dosimetry lab methods, equipment qualifications, and equipment validation, providing guidance and feedback.
* Support laboratory set-up and maintenance of laboratory equipment and consumables.
* Drive the laboratory training program, emphasizing safety rules and regulations, and ensuring all personnel are trained on safe work practices.
* Review laboratory results to ensure accuracy of data and timely communication of results.
* Ensure the dosimetry lab is validated and controlled, complying with internal requirements, applicable regulations, and ISO11137 standards.
* Provide technical guidance and support in areas of dosimetric release methods, dose mapping procedures, and dosimetry curve calibration.
* Lead problem-solving efforts related to dosimetric release and provide technical advice as needed.
* Support unplanned events and raise out-of-specification results in a timely manner.
* Initiate and complete CAPAs and Change Controls in accordance with site procedures.
* Analyse product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Generate and present quarterly and annual reports.
* Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs, and Purchasing to ensure timely completion of activities.
Requirements:
* Third-level Science / Manufacturing or equivalent qualification.
* Minimum four years' work experience in a Manufacturing / Science / Quality or equivalent environment.
* Electron beam or other sterilisation technologies experience desirable.
* Knowledge in ISO 11137 desirable.
* Chemistry/Microbiology/Dosimetry Lab experience desirable.