Quality Assurance Specialist

A fantastic opportunity has become available for a Quality Assurance Specialist to join a leading global manufacturer of both human and veterinary pharmaceutical and food products based in the Somerset area. As the Quality Assurance Specialist you will be responsible for providing GMP expertise to ensure compliance to both pharmaceutical GMP and food/feed safety standards.

This is a hybrid position with the opportunity to work from home up to two days per week.

Your duties as the Quality Assurance Specialist will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for leading the site GMP Quality Risk Management process, including risk register and risk assessments. As well as reviewing and approving all manufacturing records for batch release.

2. Supporting all Quality Management Systems (QMS) processes such as investigation of non-conformances, CAPAs and change controls. Leading the site Hazard Analysis & Critical Control Point (HACCP) programme.

3. Writing, reviewing and approving of all GMP Quality documents as required. Also, identifying and implementing improvements to QA processes and supporting continuous improvement initiatives.

4. Supporting the site audit programme, including conducting audits, supporting and hosting regulatory audits. As well as conducting Quality department inductions, training and coaching on QA processes and concepts both departmentally and site wide.

To be successful in your application to this exciting opportunity as the Quality Assurance Specialist we are looking to identify the following on your profile and past history:

1. As a successful candidate you will be degree educated within a relevant scientific discipline or an equivalent qualification.

2. As the Quality Assurance Specialist, you will have proven industry experience in a GMP regulated pharmaceutical business. Experience investigating non-conformances, CAPAs and change controls.

3. You will have previous experience in a quality assurance role, have experience in the use of electronic quality management systems and trained within HACCP. Previous internal auditing experience will also be required.