1. CLINICAL/TECHNICAL RESPONSIBILITIES Undertake the routine aseptic production of both diagnostic and therapeutic radioactive me.....
1. CLINICAL/TECHNICAL RESPONSIBILITIES Undertake the routine aseptic production of both diagnostic and therapeutic radioactive medicinal products for clinical use, including investigational medicinal products for clinical trials, operating within the terms of Standard Operating Procedures. This requires regularly drawing up radioactive doses (from heavy lead pots) through heavy and bulky lead protected syringes, many calculations and following complex and precise steps. Undertake a co-ordinator and checking role during routine aseptic production; Perform a range of quality control tests on radiopharmaceuticals, using unsealed sources of radioactivity, operating within the terms of Standard Operating Procedures, to ensure compliance with pharmacopoeial standards; ensuring these results are recorded accurately and that any failures are reported. Process and calculate results from such QC tests, and enter the confirmed results on to records for verification. Carry out routine scheduled checks, readings and quality control tests for areas and equipment that the post holder is responsible for. Responsible for ensuring that all equipment and facilities for which they are responsible are maintained in such a way as to ensure correct functioning and specification. Perform microbial and physical environmental monitoring and report results operating within the terms of Standard Operating Procedures. manufacture of radioactive medicinal products, including those related to Good Manufacturing Practice, as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency). Liaise with radiopharmaceutical manufacturers to ensure a continuing provision of suitable radiopharmaceutical products to ensure continuity of service provision. Operation of the computer systems within the section. This will include responsibility for ensuring that all entries follow data integrity and data governance. Responsible for ensuring that records of procedures, which the post holder has performed or supervised, are properly completed and maintained on the paper or computer based system. The post holder will ensure that the correct data is entered at the relevant times and that, in any event, all records are up to date by the end of the working day. Plan and prioritise own and junior staff technical workload continually throughout the day. Liaise with professional and technical staff and other service users where necessary including when there are service problems and delays. Monitor and record radioactive contamination and waste on a regular basis. Deal with radiation contamination and undertaking containment and decontamination procedures where necessary and accumulate / dispose of radioactive and pharmaceutical waste in accordance with Standard Operating Procedures, in keeping with regulations of the EA including calculations of radioactivity levels. Report incidents involving health and safety, radiation protection, quality assurance. Carry out, when required, other duties appropriate to the grade that have been discussed with the post holder. RESPONSIBILITY FOR PATIENTS Professionally and legally take responsibility for providing a high standard of clinical care and supporting other staff within Radiopharmacy, Nuclear Medicine and other service users, to do likewise. Be familiar with the range of clinical applications of the full range of available radiopharmaceuticals. Demonstrate respect for patient dignity and empathy with patients and their escorts whilst working in the Nuclear Medicine clinical area, especially in difficult or emotional circumstances, using both verbal and non-verbal communication skills. 3. EDUCATIONAL RESPONSIBILITIES Contribute to the training and induction support in the technical and theoretical aspects of Radiopharmacy work, to the relevant level for trainee clinical scientists, pre-registration pharmacists, student technicians / technologists, specialist registrars, MSc students. Also to host and supervise visitors observing technical work. Plan and contribute to the provision of comprehensive training to new Radiopharmacy staff and on-going training to existing staff, in accordance with the Radiopharmacy training program, as part of the overall Pharmaceutical Quality Management System. Keep abreast with relevant legislation and guidance updates. Assist and participate in research; which may include preparing work for presentation and, when appropriate, presenting it at courses, conferences or scientific meetings and ensuring relevant information is brought back to the department. Have an agreed personal development plan and follow to meet set knowledge and competencies, and identify further training needs as required with the Chief Radiopharmacy technician 4. RESPONSIBILITY FOR LEADING AND MANAGING Participate in the monthly self-inspection of the Radiopharmacy. Pharmaceutical Quality systems and service, and in delivering the requirements of related action plans. Jointly with the Chief Radiopharmacy Technician , ensure the regular Radiopharmacy meeting is completed, and an action plan for addressing the findings is prepared as well as delivering some of the requirements of the related action plans. Ensure a safe and secure environment for staff and patients. In particular support safeguards against theft of radioactive material and ensure staff fully comply with these safeguards Jointly with the Chief Radiopharmacy Technician, co-ordinate and plan daily workload for Radiopharmacy; including preparation of a staff rota and planning manufacturing slots. Act as deputy to the Chief Radiopharmacy Technician to cover for some of the routine duties normally performed, apart from in those areas where the post-holder is not accredited to do so. These may include rescheduling and prioritising work and supervising the deployment of technical staff as well as deploying contingency plans. Act to resolve any problems that arise during manufacture, the operation of the facility and any equipment, operating within the terms of Standard Operating Procedures. Liase with Estates department, external contractors with regards to PPM and repair work of equipment, HVAC and facilities Actively participate in the Trusts appraisal process as an appraisee. Actively participate in the Trusts appraisal process as an appraiser for junior staff 5. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT All duties must be carried out in accordance with the Health and Safety at Work Act, The Medicines Act 1968, The Radioactive Substances act 1993. The Ionising radiation Regulations, The Ionising Radiation (Medical exposures) Regulation and The Data Protection Act 1984 and any other relevant Guidance notes and Departmental Local Rules Be designated as an IR(ME)R operator by the Trust in respect to Radiopharmacy technical duties and know the legal implications involved. Be designated as a Classified Worker by the Trust under the Ionising Radiations Regulations (IRR). This will include participation in personal monitoring for radioactive contamination. Work in accordance with Local Rules, relevant legislation, codes of practice and regulations relating to the use of radioactive material and, in general, to observe safe procedures and good practice in all aspects of patient investigations and radiation work. Work in accordance with SOPs, following GMP, QA and GCP. Review current practice and propose changes where appropriate where benefit to users, other healthcare professionals and patients may result, to contribute to the development of the radiopharmacy service. To review and comment on continuing appropriateness of SOPs. Adapt, and quickly respond to changes in service or departmental need. 6. RESPONSIBILITY FOR FINANCIAL AND PHYSICAL RESOURCES Order and receipt radiopharmaceuticals and other items from external suppliers using the Trust ordering system. Maintain records of receipt, storage and disposal operating within the terms of Standard Operating Procedures, to fulfil Environmental Agency regulations and GMP. Maintain adequate stock levels, stock rotation operating within the terms of Standard Operating Procedures. Source suitable and new items / manufacturers as required. Responsible for the care and safe handling of equipment and accessories in the area of work. Ensure that equipment faults are recorded appropriately and reported. Make suitable provision for the service in the event of equipment failure. Make suitable arrangements to fix the equipment failure. Ensure records surrounding the above events are maintained. Ensure contracts and waivers are in place for services as required. 7. RESPONSIBILITY FOR INFORMATION RESOURCES Ensure that data entries and print outs are presented for checking purposes in a timely and accurate manner, ensuring data integrity. Support the cascading of information through the team, department and customers. Monitor and report deficits in the data governance and data integrity of the Radiology Information System (RIS) and the Pharmaceutical Quality System (PQS), in use in the department.
