Senior Quality Assurance Specialist
4 weeks ago
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
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