QC Manager - PET Radiopharmaceuticals

ProClinical Ltd
London (Greater)
£30 - 35 per hour
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
ProClinical's client, a pharmaceutical manufacturing business, is seeking a QC Manager to be based in London on a contract basis, with the possibility of extension

Role Overview:

* Implement robust quality control regime to produce PET radiotracers
* Manage the QC analyst team
* Organising day to day testing of produced radiopharmaceuticals against documented specifications
* Documentation of the above
* Organise rotas and appropriate cover of PET radiochemistry staff for QC testing of radiopharmaceuticals in conjunction with administrative lab manager and production manager / technical lab manager
* Ensure appropriate calibration of instruments is performed and documented appropriately
* Validation of QC methods and processes
* Assistance in the validation of radiopharmaceuticals, associated equipment, processes
* Implementation of new analytical methods/procedures/instrumentation
* Trending of QC data
* Oversight and documentation of raw materials traceability, logging, receipt, testing, quarantine and release of reagents and materials for QC and production purposes
* Includes analytical methods (e.g. HPLC, TLC etc) environmental monitoring (settle plates, finger dabs)
* Close liaison with Production manager and Lab manager in smooth running of the radiotracer productions.
* To be proactive and be responsible, to ensure that regulatory and technical problems are be solved and do not present barriers to the production of radiotracers
* To take lead in drawing together the appropriate documentation for clinical trial applications by providing the required QC and validation data
* To assist in checking appropriate QC and Validation has been performed for GMP and IMP applications
* Responsibly communicate with pharmacists/QPs, chemists, scientists and clinicians involved in radiopharmaceuticals.
* To report any deficiencies in the QA/QC to the PET laboratory manager and Head of PET Chemistry
* Communicate with other scientific and technical staff to solve technical problems in a timely manner to ensure smooth production of tracers
* To take a proactive role in the planning and implementation of the new PET radiochemistry laboratories.

To Apply:

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In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.