Advanced Therapy Quality Assurance Assistant

Guy's and St. Thomas' NHS Foundation Trust; City of Westminster; Sur place; GBP 40 000 - 55 000; Plein temps

Résumé du poste

Guy's & St Thomas' NHS Foundation Trust seeks a QA professional to support all QA activities within the GMP Unit, which manufactures cell and gene therapies. The role ensures compliance with UK/EU legislation and Trust policies, handling QA questions from staff and collaborators and maintaining PQS logs.

You will review deviations, perform preventive actions and change controls, contribute to KPI reporting, and assist in PQS system design and qualification.

Qualifications

• Experience in QA activities within a GMP environment.
• Ability to interpret and apply current UK/EU legislation and Trust requirements.
• Proven involvement in deviation assessment, CAPA including change controls.

Responsabilités

• Support QA activities for the GMP Unit and respond to QA queries from staff and collaborators.
• Operate within the PQS: review planned deviations and report deviations through quality deviations to line managers.
• Assist in management and monitoring of QA/QC activities and preparation of quality data for certification of ATMPs.
• Make strategic judgments on manufacturing processes within PQS boundaries and assess material suitability.

Connaissances

QA

GMP

Quality Assurance

PQS

Change controls

Outils

Electronic PQS

Description du poste

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 elevate 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., Ourvalues 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 .