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QA and Regulatory Officer

3 months ago

Cambridge, Cambridgeshire, United Kingdom Next Phase Recruitment Limited Full time

Senior QA Officer required for a cell therapy CDMO who have a state-of-the-art facility based near Cambridge for multiproduct GMP production.

This site allows scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK.

The Senior QA Officer will be working within the Quality Assurance (QA) team reporting to the Head of Quality Assurance to establish a quality framework for effective use in the manufacture of cellular therapies.

The Senior QA Officer will contribute to promoting a culture of Regulatory Compliance, Continuous Improvement and safety awareness in our Risk-based Quality Management System (QMS), liaising with staff across the various departments within the company.

The Senior QA Officer will take a lead on risk, be actively involved in training of the QA team, and will deputise for the Head of QA leading and supervising the QA team.

The QA team are responsible for supporting colleagues, overseeing risk assessments, and Change Control processes, as well as ensuring that documentation is controlled.

This role is expected to participate in preparing the site for Regulatory inspections, including MHRA and HTA, for manufacturing cellular therapies (UK Specials and ATMPs), and an HTA licensed biorepository.

On offer for the successful candidate is the chance to join a growing organization who has invested a lot of money in a modern facility.

As well as a competitive salary and benefits package.
The role is 5 days a week on site in Cambridge.
The required skillset for the Senior QA Officer includes:

  • BSC or MSc in a life sciences subject or comparable experience - Essential.
  • Proven experience in the field of Cellular Therapies (Biotech /CMO) with experience of working in a QA role in a GMP compliant environment - Essential.
  • Experience with performing and managing risk assessments - Essential.
  • Experience of performing internal audits - Essential.
  • Experience of managing deviations, non-conformances and CAPAs - Essential.
  • Sound scientific understanding of cell and gene therapies and tissue engineered products - Desirable.
  • An understanding of COSHH and Health and Safety regulations - Desirable #J-18808-Ljbffr