Senior Quality Assurance Specialist
1 week ago
Location:
- StevenageThe post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR Tcell products in compliance with Good Manufacturing (GMP).
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
- 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
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Senior Quality Assurance Specialist
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Senior Quality Assurance Specialist
1 week ago
Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full timeBlackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and...
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer Supply Chain
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Quality Assurance Engineer Supply Chain
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Product Assurance Engineer
1 week ago
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Divisional Quality Manager- Unplanned Care
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