GMP Quality Officer

The Gene Therapy Vector Facility (GTVF) group at King’s College London manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for the treatment of cancer and rare diseases.

This post, which is supported by an Innovation Hub for Gene Therapy grant awarded to the KCL Centre for Gene Therapy for Regenerative Medicine, provides an opportunity to work within one of the largest academic GMP facilities in Europe focusing on the delivery of gene therapy products for early phase clinical trials. This post will support the translation of cutting-edge medical research into clinical application.

The Quality Officer will work as part of the Adeno-Associated Viral Vector (AAV) group to provide quality support and to ensure manufacturing activities comply with the requirements of the Pharmaceutical Quality System (PQS), and with UK and EU Good Manufacturing Practice regulations.

Task undertaken will include but not be limited to:

• document control
• assisting in providing training on the PQS and overseeing compliance of the team with the training program/ training requirements
• review of batch documentation
• supplier qualification
• participating in internal and external audits
• assisting in the implementation of PQS improvements including corrective and preventative actions.
• update equipment calibration spreadsheet and contact suppliers to arrange and schedule calibration/maintenance visits
• record incoming goods and obtain and file certificates of analysis for GMP compliance.
• issue of purchase requisitions and resolution of invoice queries.
• type, collate and circulate reports, minutes, agendas and relevant administration support papers.

The Quality Officer will report to the Head of AAV, and will work alongside members of the Quality, Production, Quality Control and Technical teams.

This post will be offered on a fixed term contract for 18 months in the first instance.

This is a full-time post - 100% full time equivalent.

Skills, knowledge, and experience

Essential criteria

Qualifications and Training

• Minimum level 4 qualification, e.g. higher apprenticeship, HNC or other Level 4 award, plus relevant work experience OR Considerable knowledge and skills gained through work experience in a relevant post, demonstrating development through progressively more demanding work (AP, I).  
• Trained in Good Manufacturing Practise and Pharmaceutical Quality Systems (AP, I) 

Skills / Experience

• Administrative skills, including Microsoft Office (I)
• Excellent attention to detail
• Experience of working within a MHRA licensed GMP manufacturing facility
• Experience in maintaining a Quality Management System, around document control, change controls, training, deviations and CAPA, quality risk management, batch release and validation.

Knowledge

• Good understanding of GMP within a Pharmaceutical Quality System  
• Knowledge of ATMP’s

Competencies

• Competent in managing and handling electronic or paper-based documentation and records (I). 
• Excellent interpersonal skills and ability to work effectively with internal and external stakeholders, record keeping and attention to detail, ability to contribute to the team success, keeping a healthy working atmosphere in the working environment (I).

Desirable criteria

• Experience with using QPULSE.
• Good working knowledge of regulations and best practice governing area of work, including Health & Safety and environmental sustainability.
• Experience in writing and quality system standard operating procedures, including change controls, deviations, non-conformances, quality exceptions technology transfer and validation related documents.

Closing date: 2^nd April 2024

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