Quality Assistant

at  Kings College London

Job id: 090367. Salary: £32,979 - £36,396 per annum, including London Weighting Allowance.
Posted: 31 May 2024. Closing date: 30 June 2024.
Business unit: Faculty of Life Sciences & Medicine. Department: Comprehensive Cancer Centre.
Contact details: Rebecca Prue. rebecca.prue@kcl.ac.uk
Location: Denmark Hill Campus. Category: Professional & Support Services.
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About us
The King’s College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages.
In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.
The GTVF is run by a large, industry-leading team of >50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trials.
About the role
The Quality Assistant will work as part of the Quality Assurance Team to provide quality support to GMP manufacturing and QC activities and ensure the activities comply with the requirements of the Pharmaceutical Quality System (PQS). The role will also support MSAT activties as applicable.
The role will perform tasks including document control for all GMP and MSAT activties, data life cycle management, collation and tracking of PQS metrics, and preparation of batch release documentation and SOPs. The role will include review of data integrity compliance of documents, managing actions arising from data integrity risk assessments and participating in internal audits.
The Quality Assistant will play a key role in ensuring the activities of the GTVF maintain compliance with UK and EU Good Manufacturing Practice regulations.
The Quality Assistant will be responsible to the Head of Quality Assurance and work with members of the team from all areas including Production, Quality Control, Technical services and MSAT.
This would be an excellent position for someone who wishes to gain an overview of all aspects of a Quality Assurance and build transferable skills.
This is a full time post (35 Hours per week), and you will be offered a fixed term contract until 17 June 2025 (maternity cover).
About you
To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• Experience in data management including maintaining databases and tracking spreadsheets.
• Experience in document control.
• Basic knowledge of a formal quality system.
• Experience in working to SOPs or written formal instructions.
• Demonstrable organisational skills and ability to balance competing demands and priorities.
• Experience in taking minutes and organising meetings.
• Excellent interpersonal and communication skills.
• Secondary Education to A level or equivalent.

Desirable criteria

• Data integrity training.
• Experience of working in or maintaining a GMP cleanroom environment.
• Working knowledge of all aspects of QA/QC in relation to production of IMPs in particular Change Control, Document Control, Process Validation, Equipment Management CAPA, Quality Risk Management.

Further information
We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.
We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King’s.
We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.
To find out how our managers will review your application, please take a look at our ‘How we Recruit’ pages.

Please refer the Job description for details