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Job Description
Diabetes Care Kilkenny: Dosimetry Laboratory Supervisor
We are seeking a highly skilled Dosimetry Laboratory Supervisor to join our team in Kilkenny. This role will play a crucial part in ensuring the effectiveness of our dosimetry monitoring program and providing technical expertise to laboratory personnel.
Key Responsibilities:
- Provide product and manufacturing support in a cGMP regulatory environment.
- Supervise, develop, and mentor employees within the team.
- Develop and drive the site dosimetry program, updating as appropriate.
- Manage and co-ordinate all the dosimetry lab activities, including coordination with providers and suppliers.
- Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Write documentation for dosimetry lab methods, equipment qualifications and equipment validation and provide guidance and feedback.
- Support laboratory set-up and maintenance of laboratory equipment and consumables.
- Drive the laboratory training program, knowing safety rules and regulations, and making sure all personnel are trained on safe work practices.
- Review laboratory results, to ensure accuracy of data and timely communication of results.
- Ensure dosimetry lab is validated and controlled and comply with internal requirements, applicable regulations and ISO11137 standards.
- Provide technical guidance and support, in the 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 required.
- 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.
What We Offer:
- Attractive compensation package that includes competitive pay, as well as benefits such as family health insurance, excellent pension scheme, life assurance, career development, and a fantastic new facility.
- Growing business with access to many more benefits.