Lead Quality Assurance Specialist

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A leading Cell therapy based biopharmaceuticals manufacturing company is looking for a Lead Quality Assurance Specialist to support in the development of a new Quality Management System (QMS) as they transition a new build site into a fully functional Pharmaceuticals manufacturing organisation.

Focusing on phase III research and products, you will be the site lead for all quality system development and implementation across this new spec site. This will be a hands-on, all-encompassing quality assurance role where you will support on all aspects from initial equipment & process qualification, through QMS and Standard Operating Procedure development, to final continuous batch release.

Based on their UK site in Hertfordshire, you will work with global sites to drive the Quality teams forward as they develop the manufacturing of their innovative products. This is an exciting new stage of the company's progress, and you would be at the forefront, spearheading the successful development. Reporting to the Quality Director, you will work autonomously, overseeing and monitoring Quality standards and supporting with new site design.

I have outlined the key experience required to be suitable for this position, so, if you fulfil the below criteria pleas get in touch so that I can provide full information on the role.

Experience required:

* 3+ years' experience within an operational Quality Assurance position within pharmaceuticals

* Strong understanding of manufacturing processes

* Strong QMS understanding - deviations, change controls, CAPA, supplier QA

* Ideally experience within aseptic or sterile small molecule manufacture

* Ability to write and approve Standard Operating Procedures and Batch documentation

* Hands-on, proactive approach

The salary on offer will be £60,000 (negotiable above this on key experience) + excellent benefits.

Applications and candidate shortlisting are already taking place, so, if this position of Lead Quality Assurance Specialist is the opportunity that you have been looking for, please apply by the link provided or contact James Ivall at Real Staffing as soon as possible to discuss the position and your application in more detail.

I hope to hear from you soon.

Sthree UK is acting as an Employment Agency in relation to this vacancy.