Senior Quality Assurance Specialist - Stevenage, United Kingdom - Autolus

Autolus

Verified Company

Stevenage, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Location:

Stevenage
Job Summary:

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 multiproduct facility delivering cell and gene therapies
Preparation, checking and issue of inprocess and Drug Product labels, ensuring compliance with the authorised template and the batchspecific/patientspecific 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 outoftrend and outofspecification 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