Senior Quality Assurance Specialist - QA Compliance

Autolus Limited; Stevenage; On-site; GBP 30,000 - 50,000; Full time

Job summary

Une entreprise de biotechnologie de premier plan cherche à recruter un professionnel en assurance qualité pour rejoindre son équipe de Product Delivery. Le candidat sera responsable de la conformité GMP et de l'amélioration continue dans un environnement dynamique et orienté vers les produits CAR T-cell.

Qualifications

• 2-5 ans d'expérience en assurance qualité dans l'industrie pharmaceutique ou similaire.
• Expérience avec les inspections de MHRA et HTA.

Responsibilities

• Maintenir les exigences de GMP dans un environnement multi-produits.
• Gestion du système de qualité et des enregistrements de production et QC.

Skills

GMP

GCP

Communication

Teamwork

Education

BSc en sciences pharmaceutiques

MSc en sciences pharmaceutiques

Job description

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 Practice (GMP). The role will be based in Stevenage.

Key Responsibilities

• Maintaining the requirements of GMP in a multi-product facility delivering cell and gene therapies
• Control of record forms for production and QC, ensuring traceability and maintaining an audit trail
• Preparation, checking, and issuing of in-process and Drug Product labels, ensuring compliance with templates and batch-specific data
• Review of Batch Manufacturing Records and QC records, and escalation of quality issues
• Authoring, approval, and review of GxP documentation
• Supplier management, including assessments, audits, and qualification/disqualification
• Materials review and release for production and QC
• Management of the Pharmaceutical Quality System (PQS), including change controls and deviations
• Continuous improvement initiatives
• Process and equipment qualification and validation
• Analytical and QC assay validation
• First point of escalation for issues and communication with QPs
• Collation and trending of Quality KPIs
• Supporting Product Quality Review
• Conducting internal audits as lead auditor
• Supporting regulatory inspections
• Line management of Junior Quality Assurance colleagues

Demonstrated skills and competencies

E – Essential, P – Preferred

Experience

• 2-5 years’ experience in quality assurance within pharmaceutical or similar industries
• Experience with MHRA and HTA inspections

Qualifications

• BSc in pharmaceutical sciences, immunology, or equivalent (E)
• MSc in pharmaceutical sciences, immunology, or equivalent (P)

Skills/Specialist knowledge

• GMP & GCP principles
• Manufacturing and testing procedures for advanced therapies
• Understanding of CAR T-cell technology
• Strong communication and motivational skills
• Ability to build cross-departmental relationships
• Teamwork and accountability
• Ability to work independently to high standards