Overview

The Senior Quality Officer will work within the Quality Assurance team (QA) to ensure all activities within the Cell and Gene Therapy (CGT) group related to the manufacture, import, testing and release of cell and gene based products meet the quality standards of the CGT group as outlined in the Quality Manual and external standards e.g. UK statutory instruments, EU Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) regulations. They will take a lead role in the investigation and closeout of deviations and quality exceptions in conjunction with the Production and QC teams including determining corrective and preventative actions and monitoring their progress. They will perform the QA sign off of operator validations and carry out initial reviews of Batch Manufacturing Records, Quality Control Records and Media Fill Records. Participation in the conduct internal and external audits including preparation of checklists, preparation of audit reports, review of proposed corrective actions and follow up on completion and closeout of the audit will form a key aspect of the role. In addition, the Senior Quality Officer will take day to day responsibility for the authorisation of the manufacturing suites for use. The Senior Quality Officer will work closely with the Head of Quality and Quality managers to drive continuous improvement of the Pharmaceutical Quality System and will be an integral member of the Quality Assurance team and work with team members across the whole of the Cell and Gene Therapy group including RandD, Production, Technical and Quality Control. The Senior Quality Officer will be responsible to the Head of Quality. This position provides an opportunity to develop a good understanding of a wide range of cell and gene therapy and Pharmaceutical Quality Systems. This post will be offered on an indefinite contract. This is a full-time post.

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