Qualified Person / Sachkundige Person (AMG)

GMP/cGMP, ICH, FDA
Ph. Eur., BP, JP, USP

- Release to market (as Qualified Person)
- Deviation Handling
- Risk Assessment/Risk Management
- CAPA Handling
- Inspection Readiness and Compliance
- Audits / Self-Audits
- PQR
- Quality Business Analyst

• Auditor
• Data Analyst
• Deviation/CAPA
• Gute Herstellungspraxis (GMP)
• Pharmazie
• Qualified Person
• Release to Market
• Risikomanagement
• Sachkundige Person (AMG)

I have entered the Business of Industrial Pharmacy in 2017 as a Trainee Qualified Person. During myTrainee-Time, I have also had the chance to gain some experience in the role of Head of Manufacture, as well as as Head of QA. My primary expertise focuses on pharmaceutics, as sterile/liquid/semi-solid and solid drug dosage forms. Since filling and getting used to the position as QP, I put efforts into changes for a lean and streamlined business process architecture.

- Microsoft Office Suite (Poweruser)
- Microsoft Excel (Programmer)

- Python (Advanced)
- C++ (Beginner)
- SQL (Advanced)

- Tableau / Power BI