ATMP Quality Assurance Associate

Guy's and St Thomas' NHS Foundation Trust; Greater London; On-site; GBP 42,000 - 62,000; Full time

Job summary

Guy’s & St Thomas’ NHS Foundation Trust is seeking a QA professional to support all QA activities in the Advanced Therapy GMP Unit, co-located with the CRF at Guy’s Hospital. You will ensure GMP compliance, maintain PQS logs, review deviations, and support audits and inspections.

You will organise systems and procedures to meet UK/EU legislation and Trust requirements, manage quality data for certification of ATMPs, and contribute to KPI reporting and internal collaborations with GSTFT and

Responsibilities

• Review planned deviations and assess impact on manufacturing/testing processes.
• Assist in management and monitoring QA and QC activities; prepare quality data.
• Make strategic judgements on manufacturing processes within PQS boundaries.
• Contribute to quality meetings; track open deviations and KPIs.
• Understand electronic PQS; assist design/qualification of new system and log maintenance.

Skills

Quality Assurance

GMP

PQS system

Deviation management

Audit & inspection readiness

Job description

Guy’s & St Thomas’ NHS Foundation Trust is seeking a QA professional to support all QA activities in the Advanced Therapy GMP Unit, co-located with the CRF at Guy’s Hospital. You will ensure GMP compliance, maintain PQS logs, review deviations, and support audits and inspections.

You will organise systems and procedures to meet UK/EU legislation and Trust requirements, manage quality data for certification of ATMPs, and contribute to KPI reporting and internal collaborations with GSTFT and