QA Officer Analytics - 18 months Mat Cover
Oxford BioMedica plc
oxford, england, United Kingdom
8d ago

Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.

Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases.

With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.

Our recent successes are driving significant growth. As such, we are looking for a QA Officer (Analytics) to join our Quality Assurance team.

Within this role you will ensure QA regulatory compliance and product quality requirements are met at all times, to facilitate product release in a timely manner, while maintaining a strong QA culture throughout the business.

Your responsibilities will include :

  • Review QC release test documentation
  • Review Quality systems documentation including Deviations, Change controls and CAPAs.
  • Review Laboratory OOS, SOPs, Policies,
  • Review bioanalytical validation documentation and equipment validation documents
  • Perform internal and external audits and support internal client audit and inspections
  • To succeed, you will have the following skills and experience :

  • Good organisational and time management skills
  • Good attention to detail
  • Able to prioritise workload
  • Able to work under pressure
  • Good interpersonal skills
  • A Levels preferably science based
  • Understanding and experience of GMP and pharmaceutical industry QA requirements in particular relating to QC release testing
  • No agencies please

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