Quality Assurance Specialist with CAR T-cell Expertise

1 week ago


Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

Autolus Limited

Salary:£60,000 - £80,000 per annum

Job Description

The post holder will be responsible for maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies. This role will involve 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.

Main Responsibilities:

  • Maintaining GMP requirements in a multi-product facility
  • Control of record forms for production and QC
  • Preparation, checking and issue of in-process and Drug Product labels
  • Review of Batch Manufacturing Records and Quality Control records
  • Authoring, approval and review of GxP documentation
  • Supplier management, including assessment and qualification of raw material suppliers
  • Materials review and release for use in Production and QC
  • Management of the Pharmaceutical Quality System (PQS)
  • Process and equipment qualification and validation
  • First point of escalation issues and communication to QPs
  • Collation and trending of Quality KPIs

Requirements:

  • 2-5 years' experience in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system
  • Experience with MHRA inspections, either as host or involved contract giver to a manufacturing site

Qualifications:

  • BSc in pharmaceutical sciences, immunology or equivalent experience
  • GMP & GCP principles, manufacturing and testing procedures for advanced therapies, CAR T-cell technology


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