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 is in a state of compliance with relevant regulatory requirements and quality standards throughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products. The role is ideal for someone who is currently working as a QA Assistant who is looking to progress up to a QA Officer role. 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
- Supporting all 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 with Audit and Supplier Management.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56512 in all correspondence.