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Lise Skytte Kirkeby

Consultant

Design Control
GMP
MDD/MDR
Project Management
Medical Device
Computer System Validation
Validation & Qualification
Facilities & Equipment

Lise holds a BEng in Health Technology from Aarhus University and has five years' experience as a consultant within the Life Science Industry. 

Lise has worked as a Design Control Specialist with class IIb medical equipment, where management and preparation of development documentation are paramount. As a Design Control Specialist, Lise has built up extensive knowledge of the various development phases, as well as the regulatory requirements that apply to the development of medical equipment. After employment at G&M, Lise has worked with Validation & Qualification within the pharmaceutical industry, where she has been responsible for preparing validation documentation such as validation plans, SAT, IQ, OQ for the final reports as XQR/VPR as well as participation in the execution of tests and deviation management. Lise manages to have the big picture in complex projects and through her ongoing certification for project management has gained a good toolbox. 

As a consultant Lise is service minded. She strives for good and effective results where quality is in focus. Lise works analytically, systematically and cares for the detail.  

“I like challenges, and my curiosity drives me. I am hardworking, energetic and take pride in performing my work with great precision and a high level of quality. I like to be well prepared and punctual. I believe in the open dialogue, where honesty, knowledge sharing, and cooperation brings us closer to the goal together”.