Senior Quality Assurance Specialist

Found in: Talent UK C2 - 2 weeks ago

Stevenage, United Kingdom Autolus Limited Full time

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 
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

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