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Kirsti Mortimer

GCP Compliance Manager

I joined the team at NDORMS in June 2018, as the Good Clinical Practice Compliance Manager.  Having always worked in the private sector, in the Pharmaceutical, Medical Device and Veterinary industry, I welcomed the opportunity to work within academia and particularly within QA at the Botnar Research Centre. 

My role here is to assist in carrying out Audits, but more importantly, to ensure Good Clinical Practice is compliant throughout the course of the studies; so that ultimately all the Clinical Trials that are run through OCTRU have clear, concise and full traceability as they progresses from inception to completion and onto archive.

I bring with me an eclectic knowledge base of working within a Quality environment, from both health and veterinary industries, all of which have required strict adherdance to guidelines from Regulatory bodies around the world, such as FDA, MHRA and others. Previously I worked as a Large Animal Technician within a Veterinary Hospital and this is really, where my specific interest in Quality started to emerge, moving then into the Medical Device Industry to become a Test Laboratory Lead for R&D.  There I trained to become a SME in Validation and then moved forward towards the Pharmaceutical Industry were I become a Validation Specialist in all areas from equipment & utilities to process control strategies, with extensive knowledge of ISO standards along with GMP, GDP, GLP, GEP, Aseptic processing and cleanrooms.  In addition, more recently working as a Quality Assurance Engineer overseeing the management of CAPAs, Change Control, Deviation etc. and leading in FMEA, DMAIC and iSix Sigma Root Cause Analysis to ensure good practice and delivering continuous improvement. I am Lean Six Sigma and GreenBelt qualified, and a member of the Chartered Institute of Quality. 

In my spare time, I like to do the generic hobbies synonymous with relaxing such as reading, films, dog walks etc., but I also like to challenge myself and try new things. I enjoy road cycling and I am also an active member of the City of Oxford Rowing Club.