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SalaryJob id: 085607. Salary: £37,332 - £38,966 per annum, including London Weighting Allowance.
Posted: 08 March 2024. Closing date: 02 April 2024.
Business unit: Faculty of Life Sciences & Medicine. Department: Gene Therapy and Regenerative Medicine.
Contact details: Heather Kneale. heather.kneale@kcl.ac.uk
Location: Guy's and Denmark Hill Campuses. Category: Professional & Support Services.
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Job description
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 an a fixed term contract for 18 months in the first instance.
This is a full-time post - 100% full time equivalent.
Key responsibilities
Oversee document control activities, including annual / bi-annual review of documents, issuing document IDs, review and activation /approval of documentation, issuing batch record documents and maintenance of the document control database.
Oversee the monitoring and tracking of personnel training.
Carry out initial reviews of batch documentation.
Carry out the qualification of suppliers as per the PQS requirements.
Carry out the issuing / approval of labels used in manufacturing and QC testing.
Draft quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records.
Participate in the conduct of internal and external audits.
Participate in Quality Management procedures, including leading and tracking of change controls, deviations, non-conformances, quality exceptions; and the collation of metrics relating to the performance of the PQS.
Participate in new product or process introduction activities, including writing and reviewing technology transfer and validation related documents.
Participate in the authorisation of manufacturing facilities for use, including review and approval of weekly facility and equipment logs and out-of-specification (OOS) events. Raising Quality Expectation Records (QER) in the event of an OOS events and following the QER through to closure.
Support the Technicians in the purchase, review and approval of critical reagents and materials, including any associated administrative tasks, whilst adhering to King’s principles of ethics and sustainability.
Support the completion of a variety of other administrative tasks for GMP compliance, including taking meeting minutes.
Manage own workload, pattern of work and resources based on an agreed work plan.
Be responsive to changing priorities and an evolving environment/context, maximising the efficiency of the technical support being provided.
Forge relationships with colleagues in the university and externally, to build relationships, disseminate and get information, coordinate, and deliver the service.
Communicate complex information in a clear and precise way, both orally and in writing.
Use well-developed analytical skills to identify trends and patterns, using appropriate techniques and procedures to inform decisions.
Engage in Continuing Professional Development and training initiatives in line with role.
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
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.
