- Maintain batch records, equipment logs and other production records to comply with cGMP in collaboration with fellow team members.
- Maintain batch records, equipment logs and other production records to comply with cGMP in collaboration with fellow team members.
- Experience of working within a GMP environment with at least 3 years local QMS system and in compliance to EU GMP/EMA/ICH.
- Good knowledge of Quality Management System (QMS) and cGMP.
- Knowledge of regulatory guidelines and ensure compliance to EU GMP/ICH/FDA/EMA and other requirements.
- Demonstrated experience with common computer software packages (Windows, MS Office).
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Production Scientist - 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.
We are working with a clinical stage biotech company with focus on Therapy Medicinal Products (ATMPs) at the forefront of clinical medicine.
We are looking for a Senior GP Production Scientist to join the rapidly growing London based CMC division.Responsible for day-to-day operation and manufacture of the RPE ATMPs in a GMP facility