ATMP QA Associate: GMP & Compliance

Guys and St Thomas NHS Foundation Trust; Greater London; On-site; GBP 32,000 - 42,000; Full time

Job summary

Guy’s & St Thomas’ NHS Foundation Trust’s Advanced Therapy GMP Unit seeks a dedicated Quality Assurance Assistant to support QA activities and ensure GMP compliance for ATMP manufacturing and trials. You will handle deviations, CAPAs, change controls, and collaborate with GMP production and QC teams.

The role requires experience with electronic PQS systems, environmental monitoring data, and calibration of QA processes to meet UK/EU regulations.

Qualifications

• Experience in QA for ATMP manufacturing.
• Knowledge of PQS, CAPAs and change controls.
• Experience with electronic QA systems and batch records.

Responsibilities

• Support QA activities for the GMP Unit and provide day-to-day QA support.
• Assist in management and monitoring of QA and QC activities; prepare quality data for certification of ATMPs.
• Contribute to metrics, deviations tracking, and KPI reporting; assist with ePQS implementation and validation.

Skills

Quality Assurance

GMP

ATMP manufacturing

Data analysis

Tools

ePQS

Job description

Guy’s & St Thomas’ NHS Foundation Trust’s Advanced Therapy GMP Unit seeks a dedicated Quality Assurance Assistant to support QA activities and ensure GMP compliance for ATMP manufacturing and trials. You will handle deviations, CAPAs, change controls, and collaborate with GMP production and QC teams.

The role requires experience with electronic PQS systems, environmental monitoring data, and calibration of QA processes to meet UK/EU regulations.