QC Analyst - PET Radiotracers

ProClinical Ltd
London (Greater)
£25 - 30 per hour
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
ProClinical's client, a pharmaceutical manufacturing business, is seeking a QC Analyst to be based in London on a contract basis, with the possibility of extension.

Role Overview:

* Supporting all radiotracer QC activities, complying with Good Manufacturing Practice (GMP), Standard Operating Procedures (SOPs) and other relevant regulations/policies.
* Preparing documentation to support QC activities (e.g. SOPs, validation documentation).
* Ensuring appropriate maintenance and calibration of QC instrumentation is performed in a timely manner.
* Implementing and validating pharmacopoeia analytical methods and analytical methods developed by translational/implementation radiochemists for the quality control of radiopharmaceuticals, while evaluating these methods and procedures to determine how they might be improved.
* Performing stability testing of radiotracers during the process validation, using instrumental (HPLC, IC) techniques, as appropriate.
* Trending of QC data
* To monitor, interpret and apply current guidelines/regulations
* To assist in checking appropriate QC and validation has been performed for GMP and IMP applications
* To support the research chemists and production chemists in developing the required paperwork for radiopharmaceutical production
* To assist the Quality Manager in the conduct of internal audits and inspections
* Taking an active part in the management and documentation of raw materials traceability (logging, receipt, testing, quarantine, request and collection of CoA, and release of reagents and materials) for QC and production purposes.
* Training other members of staff to perform QC analysis of radiotracers.
* To assist in literature searches required for radiotracers
* After initial direction, the post holder will be required to work with minimum supervision. The post holder must be able to manage his/her own time and workload efficiently and effectively. This also requires a confidential and methodical approach with a flexible and adaptable work ethic.
* Liaising closely with production radiochemists in smooth running of the radiotracer productions.
* Reporting any deficiencies in QC to the senior PET centre staff the PET QC manager and Head of PET Chemistry and QP.
* To adhere to an agreed schedule based on the requirements of the clinical research scanning program.
* Prioritize the projects and jobs that need doing.
* To assist in ensuring the appropriate validation methodology is used for production of new tracers.
* To assist in developing and validating new and existing processes.
* To assist in the prevention, detection and management of clinical research fraud, malpractice and misconduct.
* Ability to assess the quality of produced radiopharmaceuticals to European Pharmacopoeia standards (e.g. HPLC, LAL testing etc.)
* Collect and analyse QC data/test results

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.