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Guy's and St Thomas' NHS Foundation Trust

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Contact
- Address
- Trust Offices
- St Thomas' Street
- London
- SE1 9RT
- Contact Number
- 020 7188 7188
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Advanced Therapy Quality Assurance Assistant
Accepting applications until: 11-Aug-2025 23:59
Vacancy status: Open
Accepting applications until: 11-Aug-2025 23:59
Key details
Location
- Gwefan
- Guy's Hospital, CRF GMP Unit, 15th Floor Tower Wing
- Cyfeiriad
- Great Maze Pond
- Tref
- London
- Cod post
- SE1 9RT
- Major / Minor Region
- London
Contract type & working pattern
- Contract
- Permanent
- Oriau
- Full time - 37.5 hours per week
Salary
- Cyflog
- £42,471 - £50,364 p.a. inc HCA (pro rata)
- Cyfnod cyflog
- Yearly
- Gradd
- (NHS AfC: Band 6)
Specialty
- Prif leoliad
- Biomedical Research
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup. St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’. Our adult community services achieved a rating of ‘outstanding’.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.
Trosolwg o'r swydd
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.
Advert
• 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 escalate upcoming overdue items to appropriate personnel including the Heads of unit
Gweithio i'n sefydliad
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:
Our values help us to define and develop our culture, what we do and how we do it. It is important that you understand and reflect these values throughout your employment with the Trust.
The post holder will:
· Put patients first · Take pride in what they do · Respect others · Strive to be the best · Act with integrity |
Our values and behaviours framework| describes what it means for every one of us in the Trust to put our values into action. The framework can be found on our Trust careers pages and GTIntranet .
Swydd-ddisgrifiad a phrif gyfrifoldebau manwl
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 mico exceptions within the cleanroom. The postholder will be 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.
Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.
Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.
As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.
Flexible working
We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.
Your e-mail address is important to us - We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis.
Please apply for this post by clicking "Apply Online Now."
Person specification
Qualifications
Meini prawf hanfodol
- BSc in Immunology, Haematology or equivalent experience
Meini prawf dymunol
- PhD and/or MSc in Immunology, Haematology or equivalent
Experience
Meini prawf hanfodol
- 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
Meini prawf dymunol
- 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
Meini prawf hanfodol
- Ability to work independently
- Ability to work collaboratively and as part of a team
- Ability to communicate complex ideas verbally and in writing.
Meini prawf dymunol
- Specialist knowledge of deviation management within a pharmaceutical quality system
- Experience in training staff and students
Further details / informal visits contact
- Enw
- Sakina Gooljar
- Teitl y swydd
- Head of Advanced Therapy Quality
- Cyfeiriad ebost
- [email protected]
- Gwybodaeth i gefnogi eich cais
Sakina Gooljar
Head of Advanced Therapy Quality
0207 188 7188 ext 54880
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