- Document Control systems
- Change Controls
- CAPA - Corrective and Preventative actions
- Deviations & OOS reporting
- Compliant and recall handling
- Performing internal Audits
- Write and review of documents - SOPs, Qualification/validation reports and batch records
- Subject Matter Expert (SME) for QA according to relevant regulatory authority cGMP.
- Regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP's.
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Compliance Assurance Manager
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Quality Assurance Manager - Greater London, United Kingdom - Northreach
Description
Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
I am working with a Clinical stage biotech company that are pioneering the development of regenerative medicines. There is a pipeline of several ATMPs that are at the forefront of clinical medicine for ocular diseases. They are looking for a QA Manager, you will be responsible for providing QA Support to manufacturing operations.
Are you a QA Manager that has experience
Performing QA Duties to ensure manufacturing, testing and clinical trial activities that comply with GMP, GCP and other regulatory guidelines
If you are on the lookout for a new exciting position with an exciting startup ATMP company, then look no further. Please apply with an up to date copy of your CV