Опубликовано в: Другое в Лондон | Размещено: |
Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.
What will you be doing?
* Works within established processes, guidelines and methods ensuring quality guidelines are adhered to
* Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
* Day to day responsibilities include the following elements of the PQS relating to manufacture and testing of cellular therapies including;
* Document control system, Training system, Change controls
* Corrective and preventative actions (CAPA)
* Deviation & OOS reporting
* Quality risk management
* Participating in internal audits
* Vendor qualification
* Batch record review prior to QP release
* Maintaining product specification files for ATIMP’s
* Participates in risk assessment and investigations as required
* Draft, review and approve Quality and GxP related documentation
* Provides advice and guidance to the Quell manufacturing and QC teams on Quality related issues
* Assists in the generation of quality metrics
* Highlights quality related matters or risks to others that could impact product quality, product release or regulatory compliance.
* Provides general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
* Promote quality culture and one of continuous improvement within team
What are we looking for?
* Min 2 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
* Experience in providing pragmatic quality advice to manufacturing and quality control functions
* Experience writing and reviewing GxP documents (including SOPs) to ensure good documentation, data integrity, GxP, quality and regulatory requirements are met.
* Working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products is desirable
* A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s is required
