QA Officer
Chloe Merrill is recruiting for a Quality Assurance Officer on behalf of a growing Cell Therapy CDMO to be based at their site near Cambridge on a permanent basis.
About the Company:
Our client is based in state of the art facilities for multi-product GMP manufacturing. Their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.
Job Summary:
The QA Officer will be responsible for ensuring the QMS isin a state of compliance with relevant regulatory requirements and quality standards throughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products.
About the role:
- Writing and reviewing Quality documents, Standard Operating Procedures (SOPs) and policies
- Supporting the operation of the Quality Management System including document control and review, labelling, issuing validation plans and, performing risk assessments
- Supportingall departments with writing and assessing change controls, non-conformances, root cause analysis, risk assessments and review of Corrective and Preventive Actions (CAPAs)
- Participate in the inspection process by Regulatory bodies, such as the MHRA and HTA
- Carry out and support audits and inspections, including internal audits and client audits
About you:
- BSc in a life sciences subject or related discipline or, comparable experience
- Proven experience in cellular and/or gene therapies (Biotechnology /CMO) working in a QA role, preferably in a GMP compliant environment
- Experience in writing QA documents, especially SOP’s, labels and forms
- Experience with performing and managing risk assessments
- Experience of performing internal audits
- Experience of managing deviations, non-conformances and CAPAs
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56299 in all correspondence.
