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.
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
- 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
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56299 in all correspondence.