Christian Gausepohl, PhD

As the Global Quality Director and Qualified Person of Marken Germany GmbH, Christian Gausepohl is responsible for quality and compliance issues. He previously held the position of Technology Officer and Qualified Person at Rottendorf Pharma. His responsibilities included all aspects of quality and compliance. He has worked in many different positions and has extensive audit and inspection experience with authorities, customers and suppliers. His main concern is the practical implementation of GMP requirements.

After graduating in pharmacy and receiving his PhD in Pharmaceutical Technology, he started his professional career in galenic development at Rottendorf Pharma GmbH in 1998. He held managerial positions in production, validation and technology transfer, was responsible for quality assurance and quality control and was strongly involved in the development of a robust QM system.

He has been head of the entire Quality Unit since 2013, spending his time balancing the different requirements of national and international customers and authorities using the established systems and processes. He also works for national and international organisations and associations and lectures on issues that affect the practical implementation of GMP requirements.

He is author or co-author of the following chapters of GMP Compliance Adviser:

1.E Deviation management
1.F Management of corrective and preventive actions (CAPA management)
1.J Product Quality Review and Annual Product Review
10.A Industrial Hygiene
10.B Personnel Hygiene
10.C Production hygiene
10.D Hygiene plan
11 Production
13.A Packaging materials
13.B Packaging process
16.A Storage
16.B Storage areas
16.C Storage conditions
16.D Incoming goods
17.A Contract manufacturing
18.I Qualification of suppliers
21.E Self-inspection

Back