Senior Quality Assurance Specialist - QA Compliance

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 Job assessments.
• 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

Demonstrated skills and competencies
E – Essential P – Preferred

Experience
• 2-5 years’ experience (ideally industrial) in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system
• Experience with MHRA (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site.

Qualifications
• BSc in pharmaceutical sciences, immunology or equivalent experience (E)
• MSc in pharmaceutical sciences, immunology or equivalent experience (P)
Skills/Specialist knowledge
• GMP & GCP principles
•Manufacturing and testing procedures for advanced therapies
•The basis of CAR T-cell technology • Good communication skills and ability to motivate colleagues
• Ability to build strong collaborative cross-departmental relationships
• Skills to work within a team, understanding his/her responsibilities and delegating to others and remain accountable for his/her work
• The ability to work independently to a high standard with minimal direction from a manager