QA Specialist
Motherwell
Permanent
£30,000 - £33,000
CDM Life Sciences, working with an emerging immunotherapy company developing cell-based treatments for cancer and severe viral infections are keen to speak with experienced Quality Assurance Specialists to join our client’s team on a permanent basis. The successful candidate will report directly to the QA Manager.
The position will have responsibility for ensuring Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage and distribution of manufactured drug products are compliant with current GMP and company expectations.
Responsibilities
* Provide QA input to activities including review and approval of risk assessments, specifications, Standard Operating Procedures, and other documentation types as required.
* Review and approve batch manufacturing data sets in accordance with procedures for GMP, prior to passing to Qualified Person for batch confirmation / certification. Where potential issues exist, these are to be highlighted to the QA manager.
* Participate in review of related investigations/audits/change controls, assist in the development and approval of effective CAPAs in order to resolve internal and external issues as they arise.
* Identify and escalate any identified cGMP areas of concern.
* Provide general support to all Quality unit activities relating to GMP, GCP, and other similar Quality Systems est...