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Charlotte Brus Mortensen

Senior Consultant

Quality Assurance
Deviations/CAPA
Design Control
GMP
MDD/MDR

Charlotte holds a master’s degree in Pharmacy from The University of Copenhagen. She has more than 12 years of experience with quality control, quality assurance and design control within the pharma and medical device area.

Previously, Charlotte worked 8 years in the Medicines Control Division in the Danish Medicines Agency gaining a keen eye for critical review of documentation and obtaining extensive knowledge of the regulatory framework for the pharmaceutical industry. She has also worked with class III medical device implants as a Quality Engineer supporting the CAPA - and Change Control Process with her strong quality mindset. Latest, she has worked as a Senior Consultant, primarily supporting small enterprises in developing the technical documentation for their medical devices in accordance with the Medical Device Regulation.

"I am a forthcoming and inquisitive person and enjoy teamwork and meeting new people.

I seek improvement in current practice by challenging the underlying reasons and behaviours. I am driven by my quality mindset and focus on patient safety and strive to develop coherent high-level documentation, which will meet the requirements of regulators. In my work approach, I am focused on knowledge sharing and clear communication with my team and stakeholders to ensure consensus on both the process and the project targets”.