- Ensuring compliance with GMP and other regulatory requirements; be the Quality point of contact for CMC external parties; manage the review and timely closure of manufacturing and/or release and stability testing deviations or change controls.
- Responsible for management of the CMC part of the annual External/Supplier audit programme
- To provide guidance for higher level decisions required for change management and deviation investigations, as required.
The preferred candidate for the role will have extensive experience in GB and EU GMP regulated environments and would have acted as quality manager in a pharmaceutical or Biotechnology organisation with Biologics manufacturing experience. The ideal candidate will also have good understating of IMP manufacturing and extensive expertise of EU, MHRA and FDA requirements
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
STR Limited is acting as an Employment Agency in relation to this vacancy.
