Job summary
Employer heading
QA Lead Radiopharmacy
Band 8b
Job overview
This is an exciting opportunity for a highly driven, experienced individual to lead on 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 responsible for all aspects of the quality assurance and quality control and will also act as the Head of Quality Control under MHRA 'Specials' licence.
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 Lead QA Radiopharmacy you will ensure the Radiopharmacy complies with all relevant regulations. You will continue to develop the Radiopharmacy clinical expertise and oversee the implementation of new technologies and the introduction of preparation and clinical application of new products.
We are seeking a dynamic individual with extensive aseptic and radiopharmacy experience. You must have the vision to develop the radiopharmacy quality assurance and control service so that is consistent with our state-of-the-art facilities and so that it is an exemplar service that is fit for the future.
Please note that the vacancy may close early if a suitable amount of applications are received.
Main duties of the job
- Lead QA 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 required to lead Radiopharmacy Manufacturing Unit Quality Assurance team and be named as a Quality Controller on MHRA Special licence.
- Post-holder will be responsible for overseeing the quality function of the radiopharmacy department in line with Eudralex Vol. 4 Part 1 Chapter 2
- Lead QA Radiopharmacy will be supporting Chief Radiopharmacist 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 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.
Working for our organisation
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 https://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf
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Facebook - Liverpool University Hospitals Careers
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Twitter - @LUHFTcareers
Detailed job description and main responsibilities
- The post-holder will be required to deputise for the Chief Radiopharmacist in their absence.
- The post-holder will be managing Quality Assurance / Quality Control team.
- The post-holder will participate in operational service planning and development of business plans for significant changes to the service.
- 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 be responsible for ensuring 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.
- The post-holder will provide support to the Chief Radiopharmacist when required, allowing for flexibility in working patterns to promote efficiency in the Radiopharmacy.
- The post-holder will act as the Trust expert advisor in matters concerning the radiopharmacy including provision of advice to appropriate committees, working parties and project teams as convened by the Trust. The post-holder will be expected to provide expert opinion about issues relating to the service to medical, nursing and other staff when requested.
Person specification
Qualifications
Essential criteria
- Master Degree in Pharmacy equivalent
- Registered with the General Pharmaceutical Council
- Post-graduated MSc/Diploma in Pharmaceutical Technology and Quality Assurance or equivalent experience.
Desirable criteria
- Post-graduated MSc/Diploma in Clinical Pharmacy or equivalent experience
- KCL Radiopharmacy course or equivalent
- KCL Advanced Radiopharmacy course or equivalent
- Post graduate MSc/Diploma in Management (Health Services or equivalent)
- Radiation Protection Supervisor (RPS)
Experience
Essential criteria
- Significant experience of working in Radiopharmacy or Aseptic S10 or MS special licence units in QA role
- Experience in management
- Experience in project management and service development
- 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
Desirable criteria
- Experience as Quality Controller on MHRA licence
Knowledge
Essential criteria
- Good practical knowledge of Good Manufacturing Practice (GMP) regulations
Desirable criteria
- Good practical knowledge of Good Manufacturing Practice (GMP) regulations
- Good practical knowledge or IR(ME)R 2017 regulation
- Good practical knowledge of Good Clinical Practice (GCP) regulation
- Good practical knowledge of Radiopharmacy preparation
Other
Essential criteria
- Evidence of continuing professional development and of acquiring new skills
- Demonstrate commitment to the development of others
Skills
Essential criteria
- 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
Desirable criteria
- Good understanding of the NHS and (Radio)pharmaceutical landscape
Applicant requirements
You must have appropriate UK professional registration.
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Documents to download
Further details / informal visits contact
- Name
- Dariusz Osowski
- Job title
- Chief Radiopharmacist
- Email address
- [email protected]
- Telephone number
- 07787198746
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