Job id: 079445. Salary: £36,532 - £37,182 per annum, including London Weighting Allowance.
Posted: 20 November 2023. Closing date: 03 December 2023.
Business unit: Faculty of Life Sciences & Medicine. Department: Comprehensive Cancer Centre.
Contact details: Sharon Lehec. Sharon.email@example.com
Location: Denmark Hill Campus. Category: Professional & Support Services.
THIS VACANCY IS OPEN TO INTERNAL APPLICANTS ONLY
The Cell and Gene Therapy, King's (CGT-K) 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 position is based in a team with an excellent track record in both basic and translational research.
The Quality Officer will work as part of the Quality Assurance Team to provide quality support to CGT-K manufacturing activities and ensure the activties comply with the requirements of the Pharmaceutical Quality System (PQS).
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.
The Quality Officer will play a key role in ensuring the activties of the Cell and Gene Therapy group maintain compliance with UK and EU Good Manufacturing Practice regulations.
The Quality Officer will be responsible to the Head of Quality and work with members of the team from all areas including Production, Quality Control and Technical.
This post will be offered on a fixed term contract for one year.
This is a full-time post – 100% full time equivalent.
- Oversee document control activties for the CGT-K group across all licenced sites, 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 the training of the Cell and Gene Therapy group personnel.
- Assist the Head of Quality in providing training on the PQS and developing a training manual.
- Carry out the qualification of suppliers as per the PQS requirements.
- Carry out the issuing / approval of labels used in manufacturing and QC testing.
- Carry out initial reviews of batch documentation
- Participate in the conduct of internal and external audits.
- Participate in the management of change control for both quality and manufacturing activities
- Assist the QA and Production Team in the tracking and closeout of deviations, non-conformances and quality exceptions as required.
- Draft quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records.
- Support the Cleanroom Technicians in the review and approval of critical reagents and materials
- Assist the Head of Quality with the collation of metrics relating to the performance of the PQS.
- Participate in the authorisation of CGT-K 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.
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 or higher in one of the Biological Sciences
- GMP and GCP training
- Working knowledge of all aspects of Quality Assurance in relation to production of advanced medicinal products in particular change control, document Control, training, deviations and CAPA, quality risk management
- Experience in implementing and maintaining Quality Management Systems in particular document control, deviations and CAPA, training, batch release and validation.
- Experience of working within a MHRA licenced GMP manufacturing facility and of ICH Q10 compliant Quality Systems.
- Experience in writing quality system standard operating procedures
- Experience with electronic quality management systems e.g., QPULSE and especially document control through an electronic QMS.
- Ability to build effective working relationships
- Excellent attention to detail.
- Excellent organisational skills with a demonstrable ability to balance competing demands and priorities.
- The ability to be proactive and organise own tasks
- Experience in using tools for process improvement, for example, 6- sigma
- Experience of chairing meetings and taking formal minutes
This post is subject to Occupational Health clearance.