Advanced Therapy Quality Assurance Assistant

Guy's and St Thomas' NHS Foundation Trust; Greater London; Vor Ort; GBP 42.000 - 62.000; Vollzeit

Zusammenfassung

Guy’s & St Thomas’ NHS Foundation Trust is seeking a QA professional to support all QA activities in the Advanced Therapy GMP Unit, co-located with the CRF at Guy’s Hospital. You will ensure GMP compliance, maintain PQS logs, review deviations, and support audits and inspections.

You will organise systems and procedures to meet UK/EU legislation and Trust requirements, manage quality data for certification of ATMPs, and contribute to KPI reporting and internal collaborations with GSTFT and

Aufgaben

• Review planned deviations and assess impact on manufacturing/testing processes.
• Assist in management and monitoring QA and QC activities; prepare quality data.
• Make strategic judgements on manufacturing processes within PQS boundaries.
• Contribute to quality meetings; track open deviations and KPIs.
• Understand electronic PQS; assist design/qualification of new system and log maintenance.

Kenntnisse

Quality Assurance

GMP

PQS system

Deviation management

Audit & inspection readiness

Jobbeschreibung

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.

• 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 escalation upcoming overdue items to appropriate personnel including the Heads of unit

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 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 .

The Post Holder Will

Caring – we put patients first

Ambitious – we innovate and strive for excellence

Inclusive – we respect each other and work collaboratively

For further details / informal visits contact: Name: Sakina Gooljar Job title: Head of Advanced Therapy Quality Email address: [e-mail]
Sakina Gooljar
Head of Advanced Therapy Quality
[e-mail]
0207 188 7188 ext 54880