
Dynamic Process Professional with extensive experience in the Aseptic Process Group, specializing in Environmental Monitoring and compliance enhancement at Novo Nordisk. Expertise in leveraging advanced Environmental Monitoring systems to meticulously review and edit sampling processes, ensuring adherence to Annex 1 and other regulatory standards. Proven track record in leading continuous improvement initiatives, equipment validation, and change management while fostering collaboration across diverse teams to maintain high-quality standards. With a solid foundation in Applied Physics and advanced studies in Health Informatics, committed to driving operational excellence, delivering comprehensive training, and optimizing documentation management to support pharmaceutical manufacturing goals.
Authored investigations of deviations in oral solid dose manufacturing processes. Gathered relevant data and conducted interviews with personnel to identify issues and formulate problem statements. Analyzed collected data and collaborated with subject matter experts across departments to evaluate deviation risks and apply root cause analysis methods to determine underlying causes. Evaluated all information against validated processes and equipment to assess validation status impact. Engaged key stakeholders to identify effective solutions for preventing recurrence of deviations.