Quality Assurance

7 days ago


Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
The post holder will work in the Quality Assurance Operations team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK and EU from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London.

Please note this role is based from our Stevenage site and due to the nature of supporting our Production operations, it requires onsite working so cannot be hybrid. The role is working shifts of Sunday to Wednesday, 8am to 5.45pm.

Some of the duties include:

- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for Clinical trials
- Interact with various functions to ensure cGMP compliance in batch release related activities. Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues
- 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 premises and equipment documentation this includes; protocols, reports and equipment maintenance forms
- Deviation management within a Pharmaceutical Quality System including coordinating change controls, quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions
- Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
- Supplier management: Review of supplier questionnaires, approval supplier list (ASL), management of supplier management trackers. Maintain and update eQMS records for suppliers.
- Authoring, approval and review of GxP documentation
- Collation and trending of Quality KPIs
- Report or escalate to Line Manager key progress and issues.
- To perform other duties which are directed by the line manager/QA Team Lead.
- Continuous improvement of the Pharmaceutical Quality System (PQS)



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