Qualified Person
Churchill Hospital, Oxford
Band 8C – £63,751 – £73,664
37.5 hours per week, part-time working considered
Fixed Term – 1 year (with strong possibility of extension)
Oxford is the principal site in Europe recruiting to clinical studies involving hyperpolarised Xenon imaging, notably using this method to investigate ongoing breathlessness in long-COVID. Oxford is also the first site in the world to investigate the application of hyperpolarised carbon-13 in studying cardiovascular disease.
Are you ready to bring your QP expertise to this research team to support NHS patients with access to new and novel therapies? Do you have excellent professional, organisational and delivery skills, which you can contribute to the manufacturing of medicines under MS and MIA(IMP) licenses and management of the associated quality systems? The range of medicines is currently small but specialised, and you will work closely with the Principal Investigator, Production Manager and Clinical Research Operations Manager to set-up and deliver an exciting range of trials. You will gain invaluable experience from working across sites within the organisation in delivering research excellence.
QP requirements:
- BSc in Pharmacy, Chemistry, Biology, or related subject
- Eligible to act as a Qualified Person under the requirements of 2001/83/EC
- QP Certification of investigational medicinal products
- Experience in managing a pharmaceutical quality system.
- Experience of MHRA MIA(IMP) variations and MHRA inspections
- Review and release of starting materials, intermediates and finished products
- Release of unlicensed medicinal products (‘Specials’)
Oxford Radiology Research Unit
The Oxford Radiology Research Unit (ORRU) is based at the Oxford University Hospitals NHS Trust and runs in partnership with the Oxford Biomedical Research Centre (BRC) and the University of Oxford.
ORRU leads and facilitates research and development activity with specific focus on imaging within protocols. ORRU contributes to clinical research studies to ensure the quality and provision of clinical trial services is in accordance with all relevant legislation, regulations and guidelines including Good Manufacturing Practice (GMP), International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) and Clinical Trials Directives
Closing date: 26th November 2021
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