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 Practice (GMP). The role will be based in Stevenage.
Key Responsibilities
* Maintaining the requirements of GMP in a multi-product facility delivering cell and gene therapies
* Control of record forms for production and QC, ensuring traceability and maintaining an audit trail
* Preparation, checking, and issuing of in-process and Drug Product labels, ensuring compliance with templates and batch-specific data
* Review of Batch Manufacturing Records and QC records, and escalation of quality issues
* Authoring, approval, and review of GxP documentation
* Supplier management, including assessments, audits, and qualification/disqualification
* Materials review and release for production and QC
* Management of the Pharmaceutical Quality System (PQS), including change controls and deviations
* Continuous improvement initiatives
* Process and equipment qualification and validation
* Analytical and QC assay validation
* First point of escalation for issues and communication with QPs
* Collation and trending of Quality KPIs
* Supporting Product Quality Review
* Conducting internal audits as lead auditor
* Supporting regulatory inspections
* Line management of Junior Quality Assurance colleagues
Demonstrated skills and competencies
E – Essential, P – Preferred
Experience
* 2-5 years’ experience in quality assurance within pharmaceutical or similar industries
* Experience with MHRA and HTA inspections
Qualifications
* BSc in pharmaceutical sciences, immunology, or equivalent (E)
* MSc in pharmaceutical sciences, immunology, or equivalent (P)
Skills/Specialist knowledge
* GMP & GCP principles
* Manufacturing and testing procedures for advanced therapies
* Understanding of CAR T-cell technology
* Strong communication and motivational skills
* Ability to build cross-departmental relationships
* Teamwork and accountability
* Ability to work independently to high standards
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