Advanced Therapy Quality Assurance Assistant

Job overview

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 escalate upcoming overdue items to appropriate personnel including the Heads of unit

Detailed job description and main 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 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.