We are working with one of the top global healthcare providers as they expand their operations 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.
Job Description:
You will be responsible for overseeing the operation of the ebeam sterilisation dosimetry laboratory while ensuring the effectiveness of the site's dosimetry monitoring programme in accordance with GLP, GMP, and regulatory requirements.
Your role will ensure that CAPA activities are completed effectively. You will provide direction and technical expertise to dosimetry laboratory personnel and the site.
Your 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's dosimetry programme, updating it as necessary.
* Manage and coordinate all dosimetry lab activities, including coordination with providers and suppliers.
* Ensure that all work carried out is in compliance with 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 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, and complies with internal requirements, applicable regulations, and ISO 11137 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 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.