AddressLocation:
Stevenage
Job Summary
Role Summary
The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP).
The role will be based in Stevenage.
Key Responsibilities
- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies
- Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation and archiving
- 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
- Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues
- Authoring, approval and review of GxP documentation
- Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk
- Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available
• Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions • Continuous improvement
- Process and equipment qualification and validation
- Analytical and Quality Control assay validation
- First point of escalation issues and communication to QPs
- Collation and trending of Quality KPIs
- Support Product Quality Review
- Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity
- Support regulatory inspections - backroom support and/or SME support
- Line management of Junior Quality Assurance colleagues
