Quality Assurance Specialist (Compliance)
- {{workoutLocation({display_location: '', country: 'United Kingdom', town: 'Hertfordshire'})}}
- Undisclosed
- Permanent
- Oliver Page
- 02392 314792
- Email about this job
Blackfield Associates are partnered with a cell and gene therapy organisation based in the Stevenage area, looking for a Quality Assurance Specialist (Compliance) on a fixed-term contract.
As the Quality Assurance Specialist (Compliance), you will be responsible for supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP)
Other day-to-day responsibilities include but are not limited to:
* Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, complaints, microbiological out-of-trend and out-of-specification results and other
* Authoring, approval and review of GxP documentation
* Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
The preferred candidate for the role will have extensive experience as the equivalent of a quality specialist in a pharmaceutical or Biotechnology manufacturer. The ideal candidate will also have a good understating of working in GxP environments with a degree in a relevant field.
This is a hybrid opportunity which will enable the successful candidate to WFH on a weekly basis.
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.
