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Rune Koppel

Senior Consultant

Quality control
Change control
Rune holds a MSc. in Biology from Aarhus University and has more than 10 years of experience with Quality and Compliance within the pharmaceutical industry.
From his previous positions as Senior Process Specialist and Chemist, Rune has experience with Continued Process Verification, implementation of continuous improvements in production as well as statistical analysis work in connection with processing OOS and OOE analysis results, root-cause analyzes and implementation of CAPAs and amendment cases. Furthermore, he has been responsible for the implementation and reporting of chemical and microbiological monitoring programs.
Rune has extensive experience with case processing, handling incidents in production, systematic problem solving, carrying out deviation investigations and reporting them, interpreting data and preparing change cases.
Rune works structured with a focus on finding the best possible, data-based solution for a given task. Patient safety, quality and compliance with regulatory requirements are always in focus.
"I love the redemption that occurs when the true cause of a problem is revealed. The synergy and energy that occurs when people work together, across professional groups and other divisions, I find both inspiring and deeply motivating. It is my experience, that in this way the sum is greater than the individual components - and that it is in this constellation that the best and most value-creating solutions are found."