The post holder will be part of a highly skilled team working within the Radiopharmacy, providing a wide range of radiolabelled products to numerous Nuclear Medicine departments within South Wales. They will be required to undertake a full range of technical activities involved in the day to day running of the Radiopharmacy, including radiopharmaceutical manufacture and blood labelling services as directed by the Radiopharmacy Production Manager.
This post involves complex and specialised technical work, handling radioactive substances and dealing with the hazards associated with ionising radiation on a daily basis. The post holder will be required to follow written protocols but are required to exercise some degree of individual responsibility. The role includes complying with complex legislation, supervision of trainees and junior staff with some participation in research and development work, for the benefit of the service.
Main duties of the job
* Perform and supervise the aseptic preparation and manufacture of diagnostic radiopharmaceuticals.
* Perform the complex aseptic preparation of radio-labelled blood products.
* Provide training for junior staff members, trainees and students within Radiopharmacy.
* Review, writing and implementation of standard operating procedures for both radiolabelling of 'cold' pharmaceutical products and also radiolabelled blood products.
Job description
Job responsibilities
Communication
* Effectively communicate and work as part of the Radiopharmacy team.
* Communicate issues and incidents to the Radiopharmacy management team.
* Actively participate in Radiopharmacy team meetings.
* Communicate development and training goals to junior team members and or trainees/students, as required.
Service Delivery
* Participate and supervise the aseptic preparation and dispensing of a wide range of diagnostic radiopharmaceuticals, performed following written Standard Operating Procedures (SOPs) and requirements of the Good Manufacturing Practice (GMP) and the Manufacturers Specials Licence.
* Participate and supervise the aseptic preparation of blood cell labelled products, working within the onsite dedicated blood cell labelling suite and to travel between hospital sites to carry out this procedure. Maintain high levels of concentration required to perform tasks such as, tray preparation, calculations, manufacturing of radiopharmaceuticals required for patient use. To be performed whilst working to tight deadlines while maintaining high levels accuracy, with little or no margin for error.
* Undertake quality control of radiopharmaceuticals using specialist equipment and reporting results and any defects to the Production Manager.
* Undertake work within Radiopharmacy to include the daily, weekly or quarterly aseptic cleaning and disinfection of equipment, facilities and consumables to ensure quality standards and strict GMP guidelines are maintained.
* Undertake regular operator validation tests to ensure preparation / aseptic manipulation skills are maintained to the required level.
* Receipt radioactive and non-radioactive pharmaceuticals and consumables, ensuring they are stored appropriately.
* Perform daily quality control tests on equipment reporting any abnormalities to senior staff.
* Performing radiation monitoring (including environmental contamination monitoring and appropriate decontamination and/or decay storage of radioactively contaminated items).
* Removal of waste bags and vials from the Radiopharmacy in accordance with written protocols.
Clinical
* Acting as an Operator as defined by the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) 2017.
* Undertake blood sample collection by venepuncture.
* Administer radiopharmaceuticals intravenously.
Management, Training & Leadership
* Maintaining and updating own scientific and technical knowledge of Radiopharmacy and GMP, by attending appropriate meetings, reading relevant literature and participating in a programme of continuous professional development and undertaking relevant courses, as required.
* Participate in personal training, ensuring that the appropriate level of competence is achieved whilst working in Radiopharmacy to become validated operator.
* Provide technical guidance, instruction and share best practice with junior technical staff, students, trainees and other personnel assigned to the Radiopharmacy.
* Responsible for working to a consistently high standard of work, and keeping up to date with new or amended procedures and new pharmaceutical products available.
* Maintain an up-to-date knowledge of the health board procedures for dealing with sharps, needlestick injury, infection control and clinical waste disposal and radiation protection procedures applicable to Radiopharmacy.
* Supervising trainees and students.
Digital and Information
* Undertake accurate record keeping as part of GMP and GDP practices, ensuring completion of all production documentation to provide a complete audit trail for all manufactured/dispensed products.
* Plan and prepare transport packaging and shipping certificates for transport of radioactive materials by road in accordance with the Carriage of Dangerous Goods (CDG) Regulations.
Research Development
* Undertake research programs, as required, for the development of the service.
* Participate in the introduction of potential future clinical trials, required to be undertaken by the Radiopharmacy service.
Person Specification
Qualifications
Essential
* Bachelor's degree in a relevant scientific area e.g. Nuclear Medicine or Pharmaceutical Sciences or Physical Science. Or Level 5 qualification in pharmaceutical sciences, or equivalent with relevant experience.
Desirable
* Leeds University, Aseptic preparation and dispensing of medicines course (APDM). Or Level 6 qualification in pharmaceutical sciences, Phlebotomy or Administrating Intravenous Injection course. Science Manufacturing Technician (SMT) Level 3.
Experience
Essential
* Experience of working within a GMP environment. Experience of working within an aseptic manufacturing facility, within practical experience of pharmaceutical preparation and manufacture.
Desirable
* Preparing of radio-labelled blood products. Preparation of radiopharmaceuticals. Training/supervisory experience.
Other Requirements
Essential
* Able to work between the hours of 05:00 and 17:00 with the occasional change at short notice to meet the needs of the service. Typical working pattern is 06:00 to 14:30, Monday to Friday.
Employer details
Employer name
Swansea Bay University Health Board
Address
Singleton Hospital
Sketty Lane
Swansea
SA2 8QA
Any attachments will be accessible after you click to apply.
130-HS060-0924 #J-18808-Ljbffr