Radiopharmaceutical QA Officer & Process (Cleanroom) Supervisor Band 5

This is an interesting, new, supervisor role of an aseptic suite to ensure GMP is maintained in the production of Radiopharmaceuticals, with a particular interest in Quality Assurance. The unit supplies Nuclear Medicine Imaging Department with radiopharmaceuticals daily., We are looking for an enthusiastic, meticulous person to supervise work in an aseptic suite to ensure that GMP is maintained, including monitoring adherence to SOPs and providing advice and further training to colleagues if required.
- To carry out a range of aseptic duties to ensure the smooth running of the Radiopharmacy. This will include: dispensing radiopharmaceuticals; assisting in the dispensing process, labelling and performing QC testing.
To ensure that the Radiopharmacy is continually meeting key performance targets so that patients receive a safe product., 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.

Band 5
Join us at an exciting time for Gloucestershire Hospitals NHS Foundation Trust! We have an ambitious plan for our journey to Outstanding and are looking for aspirational, committed individuals to join us, making a real difference to both staff and patients.
As a former winner of England for excellence award: Tourism destination of the year, the beautiful city of Gloucester and the scenic regency spa town of Cheltenham are fantastic places to work and live.
As a hospital Trust we are currently involved in over 100 clinical trials and studies, whilst also providing acute elective and specialist services to a population of over 620,000.
By joining Gloucestershire Hospitals NHS Foundation Trust new colleagues can look forward to a warm welcome and a future full of opportunities and support., Nuclear Medicine is one of four departments within the Medical Physics department and there are strong links and support provided by the other Heads of Department and their respective staff. The Medical Physics Department is a strong advocate for staff training and development
Gloucestershire Hospitals NHS Trust is committed to improving patient services providing Best Care for Everyone. We can offer accommodation for newly appointed staff. Gloucestershire is a pleasant place to live with easy access to the lively towns of Cheltenham and Gloucester, the Cotswold countryside, South Wales and good travel links to other parts of the UK.

If an appointable applicant does not meet the requirements for this Band 5 Role then you maybe considered for a Band 4 Role until the relevant standards have been achieved within a 2 year period.
Working hours Monday to Friday 0730-1530 hours
Expected interview date is week commencing: 13th January