QA Specialist I

2 weeks ago

London, Greater London, United Kingdom Northreach Full time

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.

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
  • Quality risk management
  • 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
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.
  • 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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