Kalsbeek Consult Aps

Kalsbeek Consult ApS was founded by Nicoline Kalsbeek in March 2019. The company has 2 employees. The Owner and Consultant Nicoline Kalsbeek is educated as Ph.D. in Chemistry and Geology, trained in Leadership and Management: EBA (Diploma of Engineering Business Administration) and has a PPL(H) Private Pilot License for Helicopter R22. Nicoline Kalsbeek has long experience in Pharmaceutical, Biotech and Medical Device industries. SERVICES • Interim Management for shorter or longer periods, experience as interim QC and QA Manager in Denmark and abroad • Coach/support for new managers or managers facing a difficult managerial task • Support with implementation of ISO 13485, MDR 2017/745 for Medical Device and IVDR 2017/746 for In Vitro Diagnostic Medical Device • Perform Internal Audits in QMS fx. ISO 13485 and the MDR • Project Management in QA/QC • Specialist in QA: Deviations, Changes, Review and Release • Specialist in QC: Deviations, Changes, Review, Optimization and Validation • Individual advice and sparring about e.g. challenges in the job, professional or relational, career opportunities or development opportunities in current job • Lectures on leadership – Why will you always succeed, when people are in focus? Tasks abroad are offered. Main languages are Danish, English and Dutch.