|Job Title:||Quality Specialist|
|Contact Name:||Julie McEwan|
|Job Published:||March 19, 2019 10:23|
This position will encompass all aspects of Quality, from oversight of the ISO 13485 QMS, CAPA’s, risk management to change controls, complaint handling and supplier quality management. Working closely with the Responsible and Qualified Person’s, in addition to the Quality Director, you will help to support the company in obtaining a Wholesale Distribution Licence and the alignment of GMP and GDP considerations with the QMS.
A healthcare research and development company focused on inhalation medical devices. Working to support third party manufacturers with their design needs, whilst also working on their own product portfolio within the smoking cessation market, due to launch later this year. It is a very exciting time for the company and the launch, planned for later this year, will see the company continue to grow.
Due to the fast-paced nature of the company and activities in the next 6 months, my client is looking for a strong all-rounder within Quality. Due to the nature of the products, you will ideally have gained commercial experience within pharmaceuticals and medical devices, although candidates that have worked solely in drug delivery devices will also be considered. Extensive ISO 13485 and GMP skills are required and working knowledge of GDP would be highly advantageous, as would knowledge of drug safety.
By virtue of the size of the company the ideal candidate will be enthusiastic, motivated and willing to get involved in problem solving and have between five and ten years commercial experience.
Candidates applying for the role must live within one hour’s commute of the office location, or be willing to relocate for the role.
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