Advanced Therapy Quality Assurance Assistant

NHS Jobs; Greater London; On-site; GBP 30,000 - 46,000; Full time

Job summary

The Advanced Therapy Quality Assurance Assistant role at NHS Jobs supports the ATMP GMP Unit with specialist QA activities, supplier approvals, and maintenance of the electronic PQS system. You will lead in data trending, non-conformance management, and CAPA escalation while training cleanroom users and ensuring proper documentation across GMP activities.

The post requires attention to detail and experience in ATMP manufacturing contexts, with opportunities to develop into a broader ATMP QA

Qualifications

• Experience in QA within GMP environments.
• Familiarity with PQS and CAPA processes.
• Ability to collate environmental monitoring data and trend results.

Responsibilities

• Provide QA support to supplier and raw material approvals.
• Assist in logging non-conformances, change controls and CAPAs.
• Train new users of GMP cleanrooms and support PQS deployment.
• Collaborate with Production and QC teams to ensure documentation accuracy.
• Assist with micro deviation investigations and documentation.
• Support Batch manufacturing record preparation for QA review.
• Maintain distribution of master SOPs and audit GMP areas.

Skills

Quality Assurance

GMP knowledge

Training experience

Data trending

Environmental monitoring

Non-conformance handling

Documentation control

Education

Bachelor's degree in life sciences

Tools

Electronic PQS

Batch record systems

Job description

Advanced Therapy Quality Assurance Assistant

The ATMP GMP Unit is looking for a highly motivated and experienced quality assurance professional who will become fully integrated within the GMP core team. This team member will have specialist quality assurance skills and ideally with some experience in ATMP manufacturing and some understanding of the challenges ATMP manufacturing poses. The applicant will be required to work alongside the core GMP Production and Quality Control team providing assistance with supplier and raw material approval. They will also be required to communicate effectively with collaborators using the GMP cleanrooms and ensure users adherence to procedures. The applicant should have some experience in providing training and will be expected to train new users of the cleanrooms in basic GMP. The individual will have some experience in using an electronic Pharmaceutical Quality System and ensuring that logging of non-conformances, change controls and corrective and preventive actions is current and escalating any actions that are becoming overdue. The selected candidate will understand how to develop metrics to monitor the effectiveness of the PQS system and to assist with improving its effectiveness. The Quality Assurance Assistant will be expected to assist in the procurement and validation of a new ePQS system for the department. The QA assistant will lead in collating environmental monitoring data, trending of data and highlighting any mico exceptions within the cleanroom. The postholder will be also be responsible for ensuring timely completion of micro deviation investigations and reporting and will be trained into completing these reports. The QA assistant will assist with collating Batch manufacturing records and making them ready for head of unit and QP review. The role requires someone with attention to detail and they will be responsible for ensuring correct distribution of master SOPs to the relevant GMP activity areas and on a regular basis auditing these areas to ensure that correct documentation is available to Production and QC staff members. All core GMP staff are responsible for assisting in maintenance of the cleanroom and this includes cleaning specific areas on a rotational basis. The QA assistant will be trained to review engineer reports and log any non-conformances raised. The selected candidate will already be an experienced QA professional but will be expected to develop further in the role to become an ATMP QA specialist.