Quality Assurance
6 days ago
The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK and EU from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. Please note this role is working Monday to Friday, 9am to 5pm with a hybrid working approach between site & home working.
Some of the duties include:
- Preparation, checking and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance;
- Environmental monitoring data management, ensuring that viable and non-viable data is collated for each batch certification requirement, and that clean-room qualification status is maintained and trended, ensuring that actions to control the environment is taken before specifications are breached;
- Collation and trending of Critical Quality Attributes data (in-process control and QC assay results) and providing statistical review to determine those that are in control and those that require attention; and
- Review of maintenance and validation documentation provided by outsourced service providers to ensure that record keeping standards have been applied, and that the service needs are met;
- Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available.
As part of the broader QA team you will also be involved in:
- Deviation management within a Pharmaceutical Quality System including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions; and
- Risk assessments with respect to product quality and health and safety.
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