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Lene Munch Nielsen

Senior Consultant

Quality management
Auditing
Deviations
GMP
Change control

Lene has a MSc. in Food Science and Technology and has more than 17 years of experience from various business areas. She has worked with product development of ingredients for the food industry and has recently acquired extensive experience in qualifying and implementing equipment/facilities used in the production of medical devices. Development, validation, implementation and monitoring of cleaning processes in a regulated production environment have been a significant part of her tasks. In addition, she has experience with change cases, deviations, risk assessments, external and internal audits.

From her previous positions as Manufacturing Engineer and Research Scientist, Lene has experience in creating an overview of complex processes and knows how collaboration with a wide range of professional groups can create positive synergies. Lene has given a good understanding of production processes by working in various production companies with both product development and production support.

Lene has a structured, analytical and solution-oriented approach to tasks and a committed focus on getting to in depth of the task. She works with a dedicated focus on quality and patient safety.

"I am motivated by the collaboration around the common goal, and to understand the context of the task in a larger context - to use the team's skills to solve complex problems, optimize processes and find the best solution, so that it provides value for the client."