Validation Manager - PCR-based IVD

Recruiter
SCI Search & Selection Ltd
Location
Newcastle Upon Tyne, UK
Salary
Competitive
Posted
13 Sep 2019
Closes
21 Sep 2019
Ref
1218651818
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Validation Manager - PCR-based IVD
Ref: SCI-00085
Our client is an exciting and highly innovative multinational company headquartered in the UK with operations and partners in the US, Asia, Europe and Africa. The Company's technology innovates the molecular diagnostic work-flow, enabling delivery of rapid actionable answers to complex clinical questions at a price point accessible to both high and low resource settings.
You will be responsible for providing specialized validation support and oversight of external CMO's, critical manufacturing suppliers and internal development. Working closely with the VP Manufacturing and within the company QMS to agree and define documentation requirements and carry out and/or oversee external CMO practical aspects of IQ, OQ, and PQ validation tasks and associated validation approach/documentation and processes.
You should have:-
* Experience of working with ISO 13485 is essential with direct experience working in the IVD industry an advantage.
* Experience of planning, undertaking and recording process and product validation is essential with experience including multi-component assembly and injection moulded parts an advantage.
* Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
* Good sense of humour and ability to adapt to a changing environment as the Company matures and moves from the R&D stage into commercialisation.
For more information please contact Andy Cuthbert on (phone number removed)

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