Radiopharmaceutical QA Officer & Process (Cleanroom) Supervisor Band 5 inCheltenham inCheltenham PUBLISHED
WED 18 DEC 2024
The position requires an enthusiastic and detail-oriented individual to oversee production processes, maintain documentation, manage stock control, and ensure compliance with safety regulations. Responsibilities also include performing audits, monitoring microbiological testing results, and participating in investigations of errors and deviations. The role offers structured training and the potential for a Band 4 position for applicants who need to meet the Band 5 requirements within two years. Working hours are Monday to Friday, 07:30 to 15:30, with interviews expected to take place in mid-January.
It is an exciting time in Radiopharmacy at Cheltenham General Hospital, as we have received the financial backing to be able to restructure and expand the Radiopharmacy team.
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.
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 hours
Expected interview date is week commencing: 13th January
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.
About us
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.
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