Lene Karina Thygesen Email & Phone Number

I have 25 years of experience in Quality assurance. I have a broad knowledge with implementation of new production, validation, and changes in general. I have extensive knowledge of GMP, GDP, ISO 9001, ISO 13485, and good skills in training, motivating and guidance people to reach deadlines and goals. I have worked abroad periodically in both China and Hungary - latest in Holland.My expertise lies in working with continuous improvements and problem solving, and I possess a well developed ability to work in a respectful and productive collaboration with other people.I have a great ability to communicate at all levels of responsibility, and I´m good at motivating people around me. I have worked abroad periodically in both China, Hungary and Holland. I have good skills to quickly create relationships, even when there are cultural differences.My competences lie within:- Non-Conformity, CAPA & Change Request- Quality assurance- Quality Management - Project management- Implementation and maintenance of QMS (ISO 9001:2015)- ISO 13485- Prepare and maintain Quality related documentation- Training and education in quality related activities - Auditing - internal/external - Preperation of validation documentation - Creation of Specifiations- Training and education in product understanding including GMP and GDP- Auditing - internal/external - Improvements within general quality, machine processes and product control (LEAN)- Start of new production setup, both in Denmark and abroad- Project-oriented tasks- Risk analysis and assessmentI am proactive, and my goal of success is when the team achieves the goals expected.I deliver tasks on time (if it´s possible) and I take pride in delivering the optimal quality level, in my assignments.I have a good sense of humor, and find myself most comfortable in a casual work environment.

Listed skills include Quality Assurance, Quality System, Quality Auditing, Quality Control, and 16 others.