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  • Location: Cambridge
  • Salary: Dependent on experience
  • Job Type:Permanent

Posted 3 months ago

  • Sector: Discovery & Translational, Quality
  • Contact: Bernie Collins
  • Contact Email:
  • Contact Phone: 01403 216216
  • Start Date: 2023-11-21
  • Job Ref: V-50232
Do you want to be involved in supporting the development of cutting-edge and breakthrough therapies? A steadily growing CDMO have opportunity for an experienced QA officer to join them on-site on a permanent basis.

What you’ll be doing

  • Writing and reviewing quality documents, SOPs and other policies
  • Supporting with QMS activities including issuing validation plans and performing risk assessments
  • Support all departments with writing and assessing change controls, non-conformances, root-cause analysis, risk assessments and CAPAs
  • Support with internal and external audits and other regulatory inspections
  • Develop and implement training materials and sessions in-house
What we need from you

  • Proven experience in cellular and/or gene therapies working in a QA role, preferably within a GMP environment
  • Experience in writing QA documents, particularly SOPs
  • Experience performing and managing risk assessments
  • Experience with internal auditing as well as managing deviations, non-conformances and CAPAs
  • Understanding of cell and gene therapies
  • A BSc in life sciences, or comparable experience
What’s on offer

  • Competitive salary
  • Additional benefits including 6% Pension
  • Excellent opportunities for growth and personal development
  • Progression opportunities