We currently have a requirement for a Dosimetry Laboratory Supervisor to join our New Abbott Diabetes Care Kilkenny site.
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-coordinate 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 everyone is 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 complies with internal requirements, applicable regulations and ISO***** 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.
Education & Experience
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 ***** 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.
Fantastic new facility.
Abbott is an equal opportunities employer.
#J-*****-Ljbffr