Qualified Person and Head of QA Pharmaceutical Projects at Dr.Falk Pharma GmbH
After studying pharmacy, Heike Meichsner first worked in a public pharmacy and then moved into industry. At CIBA, she was responsible for the logistics of clinical studies in various indications. At Gödecke, later Pfizer, she then worked for several years as a project manager in the area of product and process development. She was actively involved in the development of the management manual for the Freiburg site.
As Head of Complaints processing, she developed a new database structure. For six years, Heike Meichsner was the head of stability management, responsible for conducting and designing stability studies. During this time, she supported the development of different lean projects.
Subsequently, she led various quality assurance groups for many years, and worked as a Qualified Person. At PharmaKorell she consulted as a Senior Consultant in Quality Assurance, Quality Management and supported customers in process development and inspection preparation. She also acted as a Qualified Person. Since mid-2021, Heike Meichsner has been working for Dr. Falk Pharma in the area of quality assurance in a senior role for product and process validation and as a Qualified Person.
She is author or co-author of the following chapter of GMP Compliance Adviser: