Job summary 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. 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 https://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf Follow us on Social Media: Facebook - Liverpool University Hospitals Careers Instagram - LUHFTcareers Twitter - LUHFTcareers Date posted 28 October 2024 Pay scheme Agenda for change Band Band 8b Salary £62,215 to £72,293 a year per annum Contract Permanent Working pattern Full-time Reference number 287-DSS-511-24 Job locations Royal Liverpool University Hospital Prescot Street Liverpool L7 8XP Job description Job 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. Job description Job 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 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 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 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 Experience as Quality Controller on MHRA licence Knowledge Essential Good practical knowledge of Good Manufacturing Practice (GMP) regulations Desirable 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 Evidence of continuing professional development and of acquiring new skills Demonstrate commitment to the development of others 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 Desirable Good understanding of the NHS and (Radio)pharmaceutical landscape Person Specification Qualifications Essential 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 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 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 Experience as Quality Controller on MHRA licence Knowledge Essential Good practical knowledge of Good Manufacturing Practice (GMP) regulations Desirable 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 Evidence of continuing professional development and of acquiring new skills Demonstrate commitment to the development of others 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 Desirable Good understanding of the NHS and (Radio)pharmaceutical landscape 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). UK Registration Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Additional information 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). UK Registration Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Employer details Employer name Liverpool University Hospitals NHS Foundation Trust Address Royal Liverpool University Hospital Prescot Street Liverpool L7 8XP Employer's website https://www.liverpoolft.nhs.uk/ (Opens in a new tab)