Radiopharmaceutical QA Officer & Process (Cleanroom) Supervisor Band 5
Gloucestershire Hospitals NHS Foundation Trust
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 may be 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 Main duties of the job
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. Job responsibilities
Key result areas 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. Responsible for ensuring all products are manufactured, labelled, checked, and released in accordance with the SOPs. Ensure all relevant documentation and checks are properly completed at each key stage of the preparation. Maintain, develop and implement aseptic techniques to provide an efficient, safe service in conjunction with the Radiopharmacy Quality Manager. Ensure the Quality Management System is being maintained to meet and respond to changes in regulations and to improve production processes. Perform and ensure: audits, data recording & trending, procedure review and document maintenance are carried out, under the direction of the Radiopharmacy Manager. Review results from microbiological testing, sterility testing and monitoring for radioactive contamination. Ensure that there are the appropriate raw materials (Stock Control) to meet the demands of the Imaging Department. This may also include late requests. 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. Troubleshoot, investigate problems, and develop proposed solutions relating to production systems, processes, and equipment. Carry out and record daily contamination surveys and monitor waste during storage until disposal to comply with IRR 17 and EPR regulations respectively. Actively participate in the department's training, accreditation, re-training, validation, and re-validation program. Person Specification
Qualifications
5 GCSEs Grade 5 and above, including Grade 6 and above for Maths and English Language or equivalent. The post holders must have a qualification recognised by the GPhC, such as NVQ 3 Pharmacy Service Skills. PIPC within Aseptic Services. Cleanroom Supervision in Pharmacy Technical Services. Experience
Extensive Pharmacy or Aseptic working experience. Working in a Radiation Controlled area. Working in a Radiopharmacy under Section 10 exemption. Supervising other members of staff. Knowledge, Skills, Abilities
Good Manufacturing Practice with attention to detail. Good understanding of QAAPS. Work constructively and effectively as a member of a team. Ability to work on own initiative within competencies achieved. Maintain CPD. Manual dexterity for handling heavy syringe shields, lead pots etc behind a protective shield. IT skills: Use of Microsoft Office. Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Employer name
Gloucestershire Hospitals NHS Foundation Trust
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Gloucestershire Hospitals NHS Foundation Trust
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 may be 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 Main duties of the job
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. Job responsibilities
Key result areas 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. Responsible for ensuring all products are manufactured, labelled, checked, and released in accordance with the SOPs. Ensure all relevant documentation and checks are properly completed at each key stage of the preparation. Maintain, develop and implement aseptic techniques to provide an efficient, safe service in conjunction with the Radiopharmacy Quality Manager. Ensure the Quality Management System is being maintained to meet and respond to changes in regulations and to improve production processes. Perform and ensure: audits, data recording & trending, procedure review and document maintenance are carried out, under the direction of the Radiopharmacy Manager. Review results from microbiological testing, sterility testing and monitoring for radioactive contamination. Ensure that there are the appropriate raw materials (Stock Control) to meet the demands of the Imaging Department. This may also include late requests. 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. Troubleshoot, investigate problems, and develop proposed solutions relating to production systems, processes, and equipment. Carry out and record daily contamination surveys and monitor waste during storage until disposal to comply with IRR 17 and EPR regulations respectively. Actively participate in the department's training, accreditation, re-training, validation, and re-validation program. Person Specification
Qualifications
5 GCSEs Grade 5 and above, including Grade 6 and above for Maths and English Language or equivalent. The post holders must have a qualification recognised by the GPhC, such as NVQ 3 Pharmacy Service Skills. PIPC within Aseptic Services. Cleanroom Supervision in Pharmacy Technical Services. Experience
Extensive Pharmacy or Aseptic working experience. Working in a Radiation Controlled area. Working in a Radiopharmacy under Section 10 exemption. Supervising other members of staff. Knowledge, Skills, Abilities
Good Manufacturing Practice with attention to detail. Good understanding of QAAPS. Work constructively and effectively as a member of a team. Ability to work on own initiative within competencies achieved. Maintain CPD. Manual dexterity for handling heavy syringe shields, lead pots etc behind a protective shield. IT skills: Use of Microsoft Office. Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Employer name
Gloucestershire Hospitals NHS Foundation Trust
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