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    Radiopharmacy Quality Assurance Specialist - Sheffield, United Kingdom - Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield Teaching Hospitals NHS Foundation Trust
    Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, United Kingdom

    3 weeks ago

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    Permanent
    Description

    Job summary

    This is a band 7 post. However, candidates nearing completion of the Pharmaceutical Science STP training scheme will be considered for appointment at pre-registration level (band 6). This is for a temporary period, until obtaining registration with the HCPC.

    This is an exciting opportunity to join our friendly Radiopharmacy team manufacturing radiopharmaceuticals for Nuclear Medicine services at Sheffield Teaching Hospitals NHS Foundation Trust (STH) and the wider region. The MHRA-licensed Radiopharmacy is part of the Nuclear Medicine department and, as such, you will be working within a wider multi-disciplinary team.

    The successful candidate will have Quality Assurance responsibilities within Radiopharmacy, performing and ensuring the performance of Quality Control, Quality Assurance and Production duties associated with manufacturing safe, effective and high quality radiopharmaceuticals.

    They will deputise for the Head of Radiopharmacy (lead QA on the MHRA licence) in Quality Assurance matters.

    Main duties of the job

  • To maintain the Pharmaceutical Quality System of the Radiopharmacy to satisfy requirements of EU Good Manufacturing Practice and the Manufacturer's "Specials" Licence issued by the MHRA.
  • To support the Head of Radiopharmacy (Lead QA) in the monitoring, maintenance and development of the Radiopharmacy service.
  • To actively contribute to the collective strategic vision and mission of the radiopharmacy through individual action and inclusive, collaborative working.
  • To deputise for the Head of Radiopharmacy in Quality Assurance matters.
  • To participate in radiopharmaceutical production sessions, including the sterile manufacture of radiopharmaceuticals and the radio-labelling of autologous blood cells. Perform formal release of radiopharmaceutical products post manufacture.
  • To be available to the inspectorate of the MHRA for matters relating to the quality of manufactured medicinal products ("Specials"), in the knowledge that they have the power to withdraw licensing, if not satisfied, which would result in the cessation of the Nuclear Medicine service at multiple hospitals across the region.

    • About us

    You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.

    Sheffield Teaching Hospitals is one of the UK's leading NHS Trusts which also has an impressive track record of leading clinical research and patients and staff are not numbers they are individuals. Proud to make a Difference is not just our slogan but the way we do things. If you are looking for a role or career that excites you, stretches your potential and gives you job satisfaction, we would love to hear from you.Sheffield offers all the benefits of a vibrant university city, while its location on the edge of the Peak District means that there is easy access to countryside with renowned walking, cycling and climbing.

    Job description

    Job responsibilities

    Please view the attached Job Description and Person Specification documents for full details regarding this post.

    When completing your application please ensure that you clearly demonstrate how you meet the role criteria.

    This is a Band 7 post looking for candidates who hold the relevant UK registration. Only candidates who are in the final stages of the Pharmaceutical Science STP training scheme will be considered for the temporary pre-registration band 6 post.

    Please also note this vacancy is banded dependent upon applicants registration relevant to this post. The banding of the successful applicant/s will start at Band 6 unless applicants meet the necessary registration required to start on Band 7.

    Person Specification

    Education and Qualifications

    Essential

  • B7 Healthcare Scientist: Honours degree at a minimum of 2(ii) in suitable science subject ( physics, chemistry, biochemistry); Masters degree or equivalent in relevant subject area; Registration as a Clinical Scientist with the Health Professions Council
  • B7 Nuclear Medicine Technologist: Honours degree at a minimum of 2(ii) in suitable science subject ( physics, chemistry, biochemistry.); Post-graduate qualification in Quality Assurance or Radiopharmacy ( PTQA Post-Graduate Diploma or MSc); Registration as a Clinical technologist or healthcare science practitioner with the Health Professions Council or Register of Clinical Technologists; Masters level of knowledge/expertise in Radiopharmacy
  • B7 Pharmacy Technician: National Certificate in Pharmaceutical Sciences; Post-graduate qualification in Quality Assurance or Radiopharmacy ( PTQA Post-Graduate Diploma or MSc); Registered as a pharmacy technician on the GPhC Register; Designated Checking Certificate or completion of competency-based training in the checking and release of radiopharmaceuticals or "Specials"; Masters level of knowledge/expertise in Radiopharmacy
  • B6 Healthcare Scientist: Honours degree at a minimum of 2(ii) in suitable science subject ( physics, chemistry, biochemistry); Training and experience to support imminent registration as a Clinical Scientist (pharmaceutical scientist) with the Health and Care Professions Council

    • Desirable

  • B7: PhD or equivalent level of knowledge/expertise in Radiopharmacy
  • B6: Masters degree or equivalent in radiopharmacy, pharmacy QA or equivalent subject.

    • Experience

    Essential

  • B7 & B6: Experience of working within the specialist area of Radiopharmacy including experience of quality control testing and product release. It is generally expected that part of this experience may have been gained through structured basic and advanced training programmes
  • B7 & B6: Evidence of on-going professional development and CPD
  • B7: Competence in scientific computing and IT
  • B7 (NM and pharmacy technician/technologist only): Experience of radiopharmaceutical production for intravenous administration
  • B7 (NM and pharmacy technician/technologist only): Significant post-qualification experience working in a hospital pharmacy, in the pharmaceutical industry, or in an MHRA licensed manufacturing facility, with involvement in development of a pharmacy quality management system
  • B6: Some knowledge of the legislation, standards and guidelines relevant to the practice of radiopharmacy

    • Desirable

  • B6: Experience in implementation of quality standards and development of standard operating procedures and protocols
  • B6: Experience in radiopharmacy audit, self inspection and/or MHRA inspections
  • B6: Experience in research resulting in presentation of results via written scientific papers in peer-reviewed journals and/or oral presentation at approved scientific meetings
  • B6: Competence in scientific computing and IT
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