This is a fantastic opportunity to join a well-established bio-manufacturing organisation,
with an internationally recognised product portfolio.
Applications are sought for the above vacancy within the Quality & Regulatory Affairs Department.
The main duties of this post will be to ensure that all aspects of regulatory and GMP compliance are met through effective management of the companies Quality Management System. You will work in close conjunction with the Regulatory Affairs Section as well as other departments, to achieve sustained compliance of ISO9001, ISO13485, 98/79/EC IVD Directive, FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1.
Other responsibilities will include managing QA processes for incoming materials, developing compliance master plans and managing CAPA.
You will be required to be qualified to degree level in a relevant discipline, or possess an equivalent qualification, and have relevant work experience in a regulatory affairs and compliance environment. You should have extensive GMP auditing experience and ideally have a specialist knowledge of GMP and compliance as applied to the manufacture of diagnostic devices. Good communications skills and a working knowledge of core IT packages is essential.
Please call 0141 272 7707 for more information about this role.
Job Reference: Req//154635
Closing Date: 30-Apr-2011
