Advanced Therapy Quality Assurance Assistant

www.findapprenticeship.service.gov.uk - Jobboard; London; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading apprenticeship provider in the UK is seeking a highly motivated Advanced Therapy Quality Assurance Assistant in London. The role involves collaborating with production and quality control teams, training cleanroom users, and ensuring compliance with procedures. The ideal candidate will have specialist quality assurance skills and some experience in ATMP manufacturing, with opportunities for professional development towards becoming an ATMP QA specialist.

Qualifications

• Experience with GMP practices and environments.
• Ability to log non-conformances and manage change controls.
• Skills in data collation and environmental monitoring.

Responsibilities

• Collaborate with GMP Production and Quality Control teams.
• Train new cleanroom users in basic GMP practices.
• Assist with supplier and raw material approval.

Skills

Specialist quality assurance skills

Experience in ATMP manufacturing

Effective communication

Training skills

Knowledge of electronic Pharmaceutical Quality Systems

Tools

ePQS system

Job description

Advanced Therapy Quality Assurance Assistant

The ATMP GMP Unit is looking for a highly motivated and experienced quality assurance professional to join the GMP core team. The ideal candidate will possess specialist quality assurance skills, with some experience in ATMP manufacturing and an understanding of its challenges. Responsibilities include collaborating with GMP Production and Quality Control teams, providing assistance with supplier and raw material approval, and communicating effectively with collaborators in GMP cleanrooms to ensure adherence to procedures.

The role involves training new cleanroom users in basic GMP practices, utilizing electronic Pharmaceutical Quality Systems to log non-conformances, change controls, and CAPAs, and developing metrics to monitor and improve PQS effectiveness. The candidate will assist in procuring and validating a new ePQS system, collate environmental monitoring data, and highlight micro exceptions within the cleanroom environment.

Additional duties include ensuring timely completion of micro deviation investigations, preparing batch manufacturing records for review, distributing master SOPs, and auditing GMP areas for documentation compliance. All GMP staff contribute to cleanroom maintenance, including cleaning duties. The QA assistant will also review engineer reports and log non-conformances. The role offers opportunities for professional development towards becoming an ATMP QA specialist.