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Senior QA Officer Radiopharmacy
4 months ago
Job summary
This is an exciting opportunity for a highly driven individual to participate in the development and delivery of the Radiopharmacy quality and clinical service from our state-of-the- art facility at Royal Liverpool University Hospital.
The post-holder will be undertake quality assurance and quality control activities within the department as part of the Quality Assurance team.
The Radiopharmacy at LUHFT is designed to deliver wide range of radiopharmaceuticals for imaging, therapy and investigational medicinal products for clinical trials as well as blood labelling suite.
As Senior QA Officer you will help ensure the Radiopharmacy complies with all relevant regulations. You will continue to develop the Radiopharmacy clinical expertise and assist with the implementation of new technologies and the introduction of preparation and clinical application of new products.
We are seeking a dynamic individual with experience of working in radiopharmacy and/or technical services. Experience of working in Quality Assurance or a GMP-controlled environment is desirable.
Please note that the vacancy may close early if a suitable amount of applications are received.
Main duties of the job
Senior QA Officer Radiopharmacy will be employed by Liverpool University Hospitals NHS Foundation Trust and will be based at The Royal Liverpool University Hospital. The post-holder will be part of the Quality Assurance / Quality Control team. The post-holder will be responsible for maintaining the Radiopharmacy Pharmaceutical Quality System under the management of the QA Lead Radiopharmacy. The post-holder will be jointly responsible for organising and maintaining the Quality Control programme of the Radiopharmacy, under management of the QA Lead Radiopharmacy. Senior QA Officer Radiopharmacy will support QA Lead Radiopharmacy in providing technical and clinical advice on preparation and use of Radiopharmaceuticals to the Trust and surrounding hospitals. This includes both prepared in-house and outsourced medications. The post holder will work closely with QA Lead Radiopharmacy, Chief Radiopharmacist, Deputy Chief Radiopharmacist, Radiopharmacy Manufacturing Unit Production Manager, Nuclear Medicines Department and other departments that may require Radiopharmacy support to ensure the safe and effective operation of Radiopharmacy services.
About us
Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.
The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.
The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.
It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.
To hear more about our achievements click here
Follow us on Social Media:
Facebook - Liverpool University Hospitals Careers
Instagram - @LUHFTcareers
Twitter - @LUHFTcareers
Job description
Job responsibilities
The post-holder will be responsible for performing release of products manufactured in the Specials licensed unit. The post-holder will be jointly responsible for performing quality control testing of products manufactured in the Specials licensed unit. The post-holder will be responsible for ongoing development and maintenance of the Radiopharmacy training program, as part of the overall Radiopharmacy Pharmaceutical Quality System. The post-holder will contribute to ensuring that the department complies with the requirements for Good Manufacturing Practice, as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency). The post-holder will contribute to the provision of the routine Radiopharmacy service, including provision of diagnostic, therapeutic and theragnostic radiopharmaceuticals (including quality testing of these products) and provision of a range of in vitro tests. The post-holder will, jointly with other suitably qualified staff, provide a complex radiolabelling service (including radiolabelling of peptides for therapeutic applications). The post-holder will be required to act as a Radiopharmacy Operator, as defined by the Ionising Radiations (Medical Exposure) Regulations, 2017. The post-holder will be required to liaise with radiopharmaceutical manufacturers to ensure a quality of suitable radiopharmaceutical products to deliver continuity of service provision. The post-holder will be expected to provide advice to end users of issues relating to the safe and effective use of radioactive medicinal products, including storage conditions, formulation and potential adverse reactions. The post-holder will assist in the evaluation and validation of equipment and software for use in the Radiopharmacy. Person Specification
Qualifications
Essential
Master Degree in Pharmacy or Clinical Pharmaceutical Science Degree or equivalent Registered with the General Pharmaceutical Council or Health and Care Professions Council Post-graduated MSc/Diploma in Pharmaceutical Technology and Quality Assurance or equivalent experience
Desirable
KCL Radiopharmacy course or equivalent KCL Advanced Radiopharmacy course or equivalent Radiation Protection Supervisor (RPS)
Experience
Essential
Experience of working in Radiopharmacy or Aseptic S10 or MS special licence units in QA role - at least 2 years in Aseptic units or at least 1 year in Radiopharmacy units.
Desirable
Experience as releasing officer in MHRA "Specials" Unit Experience in Education and Training within GMP and Radiopharmacy environment Experience in validation of equipment Experience in validation of processes Experience in project management and service development
Knowledge
Essential
Good practical knowledge of Good Manufacturing Practice (GMP) regulations
Desirable
Good practical knowledge of IRR17 Good practical knowledge or IR(ME)R 2017 regulation Good practical knowledge of Good Clinical Practice (GCP) regulation Good practical knowledge of Radiopharmacy preparation
Skills
Essential
Good verbal skills Good written communication skills Logical thought processes Ability to work under pressure Ability to prioritise appropriately Ability to work as a part of a team Problem solving and decision making Good IT skills - ability to use Word, Excel, PowerPoint, and ability to learn new computer software used in Radiopharmacy
Other
Essential
Evidence of continuing professional development and of acquiring new skills. Demonstrate commitment to the development of others