QC Manager - PET Radiopharmaceuticals

Recruiter
ProClinical Ltd
Location
London (Greater)
Salary
£30 - 35 per hour
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
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:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
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.