eQMS Quality Assurance Specialist | Permanent | London | £45,000 - £65,000 pa
Blackfield Associates are carrying out a search on behalf of a cutting edge Advanced Thereapy Medicinal Product (ATMP) service provider. The successful candidate will be responsible for assuring the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end-users, and other cross-functional areas.
The eQMS specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner.
Responsibilities of the role will include but are not limited to: Selection and implementation of a QMS to support GxP activities and wider business Key input and development into QMS policies and plans Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems. Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable. Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.
The ideal candidate will be degree educated in a relevant scientific or technical discipline with several years' of related Quality, Manufacturing and Compliance experience in the Therapeutics, Biologics, Cell/gene Therapy industries. Previous capability in setting up and managing robust eQMS. It would also be highly desirable to have experience in ATIMPs and/or aseptically manufactured product. This role is office based in London, therefore in order to be considered candidates should live local to London with the intention of travelling into the city.
For more information or to apply email your cv to or call Gary on (phone number removed)
STR Limited is acting as an Employment Agency in relation to this vacancy