Clean Room Supervisor with Quality Assurance, Band 5

at  Gloucestershire Hospitals NHS Foundation Trust

Key result areas 1. Support, monitor and participate in all aspects of the production process: dispensing, assisting, packing and QC testing using appropriate radiation protection methods and aseptic techniques while ensuring compliance with SOPs, GMP, IRR17 2. Responsible for ensuring all products are manufactured, labelled, checked, and released in accordance with the SOPs 3. Ensure all relevant documentation and checks are properly completed at each key stage of the preparation.
4. Maintain, develop and implements aseptic techniques to provide an efficient, safe service in conjunction with the Radiopharmacy Quality Manager 5. Ensure the Quality Management System is being maintained to meet and respond to changes in regulations and to improve production processes. 6.
Perform and ensure: audits, data recording & trending, procedure review and document maintenance are carried out, under the direction of the Radiopharmacy Manager 7. Review results from microbiological testing, sterility testing and monitoring for radioactive contamination. 8. Ensue that there are the appropriate raw materials (Stock Control), to meet the demands of the Imaging Department.
This may also include late request. 9. Support the reporting of any errors and deviations, including out of specification results. Participate in trending, change control and CAPA investigations, including root cause analysis 10.
Troubleshoot, investigate problems, and develop proposed solutions relating to production systems, processes, and equipment. 11. Carry out and record daily contamination surveys and monitor waste during storage until disposal to comply with IRR 17 and EPR regulations respectively. 12.
Actively participate in the departments training, accreditation, re-training, validation, and re-validation program. PLEASE SEE THE ATTACHED JOB DESCRIPTION FOR MORE DETAILS

Please refer the Job description for details