Job id: 067875. Salary: Grade 6: £41,386 – £48,414 per annum, including London Weighting Allowance.
Posted: 24 May 2023. Closing date: 14 June 2023.
Business unit: Faculty of Life Sciences & Medicine. Department: Comprehensive Cancer Centre.
Contact details: Dr Rebecca Prue. Rebecca.email@example.com
Location: Denmark Hill. Category: Professional & Support Services.
The Cell and Gene Therapy, King's group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application.
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.
The Senior Quality Officer 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 R&D, 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
• Be responsible for initial completion of QA information in batch manufacturing documentation prior to commencement of manufacturing in conjunction with the Production Team.
• Carry out initial reviews of Batch Manufacturing Records, Quality Control Records and Media Fill Records
• Participate in the conduct of internal and external audits.
• Take a lead role in the investigation of non-conformance findings from internal audits and client audits.
• Take day to day responsibility for the qualification (or disqualification) of suppliers, working with QA colleagues to conduct audits and desk-based reviews.
• Take day to day responsibility for MHRA and HTA licence variations and CGT-K annual returns as applicable
• Perform the QA sign off of operator validations
• Draft and review quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records.
• Document any deviations related to duties through the PQS in a timely manner, and in accordance with written procedures. Assist in the investigation and close-out of such deviations.
• Assist in deviation management with the PQS including investigation and closeout of deviations and quality exceptions, as required, with the Production and QC teams.
• Conduct risk assessments with respect to product quality and health and safety
• Ensure that CGT-K activities conform with the requirements of the PQS.
• Take a lead role in the management of Change Control for both Quality and Manufacturing activities.
• Working with QA colleagues undertake the collation of metrics relating to the performance of the PQS.
• Undertake additional duties related to the compliance of the PQS and manufacturing activities with the applicable EU and international regulations e.g. FDA as required.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
Degree in one of the biological sciences.
1. Experience in maintaining Quality Management Systems.
2. Formal Good Manufacturing Practice training.
3. Working knowledge of a Pharmaceutical Quality System according to ICH Q10 in particular Change Control, Document Control, Deviations and CAPA, and supplier qualification.
4. Experience of working in ATMP/ IMP manufacturing setting.
5. Experience in writing SOPs relevant to ATMP/ IMP production and Pharmaceutical Quality Systems
6. Practical experience of conducting deviation investigations.
7. Experience in writing change controls and managing changes in relation to GMP facility, equipment and manufacturing processes.
8. Experience in reviewing operation validations or media fills.
9. Good verbal and written communication skills.
10. Excellent organisational skills with a demonstrable ability to balance competing demands and priorities.
1. Experience in working a MHRA licenced environment.
2. Experience in the requirements of HTA regulations and work in the compliance with these regulations.
3. Hands on experience in production of cell therapies or cell biology / immunology-based research.
Dr. Rebecca Prue, Head of Quality.: firstname.lastname@example.org