Advanced Therapy Quality Assurance Assistant

Guy'S And St Thomas' Nhs Foundation Trust

London Borough of Southwark

On-site

GBP 36,000 - 42,000

Full time

9 days ago

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Job summary

Guy's and St Thomas' NHS Foundation Trust is seeking an experienced Quality Assurance professional to join the ATMP GMP unit at Guy's Hospital. The role focuses on QA activities, PQS compliance, and collaboration with GMP production and QC teams across trials.

The post holder will manage deviations, change controls, and documentation while developing new PQS systems and ensuring timely environmental monitoring reporting.

Qualifications

2 years experience in Quality Assurance
Experience with GMP or equivalent
Experience with process qualification and equipment validation for GMP

Responsibilities

Review deviations and change controls within PQS and report findings to management.
Assist QA/QC activities and prepare quality data for ATMP certification.
Contribute to PQS design, qualification, and ongoing logs; escalate overdue items.
Collate environmental monitoring data and trending; highlight micro deviations.
Ensure proper distribution of master SOPs and audit documentation in GMP areas.

Skills

Independent work

Teamwork

Communication skills

Education

BSc in Immunology/Haematology

PhD or MSc in Immunology/Haematology

Tools

GMP systems

Job description

Job summary

The Advanced Therapy Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy's Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.

The post holder will be personally responsible for supporting all QA activities. The unit itself holds a GMP licence for manufacturing of T-Reg cell therapies and CAR T-Cell gene therapies as well as new manufacturing processes. The post holder will also be responsible for organising systems and procedures to ensure compliance with current UK & EU legislation and Trust requirements. This will also include responsibility for following policies and standard operating procedures for manufacturing and quality assurance of the GMP Unit. The post holder will be responsible for the day to day QA queries from core staff and collaborators using the unit equipment and systems and ensuring that GMP compliance is maintained.

Main duties of the job

Operate within the PQS: Reviewing Planned Deviations, by assessing impact/risk on the manufacturing or testing process prior to its implementation. Report deviations through Quality deviations to line managers. You will undertake Preventive Actions and Change Controls to rectify exceptions and implement audit and inspection findings.
Assist in the management and monitoring of QA and QC activities, ensuring that agreed quality standards of service are maintained. Enable preparation of quality data to be used in the certification of ATMPs.
Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the PQS, such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
Contribute to quality meetings internally and with collaborators, tracking the progress of open deviations and reporting on KPIs
Understand how an electronic PQS operates and assist in the design and qualification in a new system. Have the ability to keep PQS logs current and elevate upcoming overdue items to appropriate personnel including the Heads of unit

About us

Guy's & St Thomas' NHS Foundation Trust (GSTFT) and King's College London (KCL) have formed a centre that has a strong focus on translational research taking advances in basic medical research out of the laboratory and into the clinical setting, forming a key part of the Department of Health's new strategy for research and development in the NHS. The Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy's Hospital. The GMP Unit is purpose built for the manufacture of somatic cell therapies, gene therapies and proteins for early-phase clinical trials. It is used by staff from different departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.

Organisational Values

Caring - we put patients first
Ambitious - we innovate and strive for excellence
Inclusive - we respect each other and work collaboratively

Job responsibilities

The ATMP GMP Unit is looking for a highly motivated and experienced quality assurance professional who will become fully integrated within the GMP core team. This team member will have specialist quality assurance skills and ideally with some experience in ATMP manufacturing and some understanding of the challenges ATMP manufacturing poses. The applicant will be required to work alongside the core GMP Production and Quality Control team providing assistance with supplier and raw material approval. They will also be required to communicate effectively with collaborators using the GMP cleanrooms and ensure users adherence to procedures. The applicant should have some experience in providing training and will be expected to train new users of the cleanrooms in basic GMP. The individual will have some experience in using an electronic Pharmaceutical Quality System and ensuring that logging of non-conformances, change controls and corrective and preventive actions is current and escalating any actions that are becoming overdue. The selected candidate will understand how to develop metrics to monitor the effectiveness of the PQS system and to assist with improving its effectiveness. The Quality Assurance Assistant will be expected to assist in the procurement and validation of a new ePQS system for the department. The QA assistant will lead in collating environmental monitoring data, trending of data and highlighting any micro exceptions within the cleanroom. The postholder will also be responsible for ensuring timely completion of micro deviation investigations and reporting and will be trained into completing these reports. The QA assistant will assist with collating Batch manufacturing records and making them ready for head of unit and QP review. The role requires someone with attention to detail and they will be responsible for ensuring correct distribution of master SOPs to the relevant GMP activity areas and on a regular basis auditing these areas to ensure that correct documentation is available to Production and QC staff members. All core GMP staff are responsible for assisting in maintenance of the cleanroom and this includes cleaning specific areas on a rotational basis. The QA assistant will be trained to review engineer reports and log any non-conformances raised. The selected candidate will already be an experienced QA professional but will be expected to develop further in the role to become an ATMP QA specialist.

Person Specification

Qualifications

Essential

BSc in Immunology, Haematology or equivalent experience

Desirable

PhD and/or MSc in Immunology, Haematology or equivalent

Experience

Essential

2 years experience working in Quality Assurance
Expert knowledge and hands on experience of Good Manufacturing Practice (GMP) or equivalent.
Experience with process qualification, and equipment validation for GMP

Desirable

Specialist knowledge relating to the manufacture of somatic cell and gene therapy products within GMP
Experience in cellular immunology techniques and analyses: proliferation, characterisation, and safety tests
Specialist knowledge of: environmental monitoring, GMP unit cleaning, maintenance and qualification of specialist equipment

Skills

Essential

Ability to work independently
Ability to work collaboratively and as part of a team
Ability to communicate complex ideas verbally and in writing.

Desirable

Specialist knowledge of deviation management within a pharmaceutical quality system
Experience in training staff and students

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name: Guy's and St Thomas' NHS Foundation Trust
Address: Guy's Hospital, CRF GMP Unit, 15th Floor Tower Wing, Great Maze Pond, London, SE1 9RT, United Kingdom
Employer's website: https://www.guysandstthomas.nhs.uk/careers/careers.aspx

Employer contact details