Role Overview
We are currently looking for a Quality Assurance Specialist to join a leading biopharmaceutical services organisation based in the South West of the UK to join their team.
Our client specialises in supporting the manufacture of cell and gene therapies (CGT) and biopharmaceuticals. As a Quality Assurance Specialist, you will play a key role in supporting the Pharmaceutical Quality System (PQS), collaborating across Quality, Production, and QC teams to ensure compliance across a range of innovative and regulated manufacturing projects.
Key Duties And Responsibilities
Your duties as the Quality Assurance Specialist will be varied however the key duties and responsibilities are as follows:
* Support the Quality Manager and Senior QA Specialists in maintaining oversight of the PQS, including deviation and issue management, change control, validation activities, out-of-specification results, supplier oversight, and self-inspections
* Complete reviews of production batch records and QC test data
* As the Quality Assurance Specialist you will maintain and support the documentation control system, including SOPs, batch records, validation protocols, and QC reports
* Ensure the timely investigation and closure of deviations, audit findings, and out-of-specification events
Role Requirements
To be successful in your application to this exciting role as the Quality Assurance Specialist, we are looking to identify the following on your profile and past history:
* A Degree or higher level in a relevant scientific subject area (Pharmaceutical Chemistry / Quality Assurance / Quality Management). Proven experience in GMP functions across QA, QC, or Production
* Demonstrated experience in GMP-regulated environments, including Quality Management Systems, risk management tools, deviation/CAPA processes, and document control
* Familiarity with HTA, FDA, and UK/EU regulations, and previous exposure to CDMO or ATMP environments would be advantageous
WHAT'S IN IT FOR YOU?
You will join a respected and growing organisation with global recognition in CGT and biopharmaceutical manufacturing. As a Quality Assurance Specialist, you will have the opportunity to influence quality culture, support impactful clinical projects, and further develop your career in a highly innovative and purpose-driven environment.
Key Words
Quality Assurance Specialist / QA / GMP / PQS / Biopharmaceuticals / Cell and Gene Therapy / ATMP / Documentation / Validation / CAPA / CDMO / Regulated Environment / South West / Pharmaceutical QA
Hyper Recruitment Solutions Ltd (HRS)
is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career