Dr. Michael
von Gönner
Senior Quality Consultant – Life Science
Doctorate in biology, with over 20 years of broad management experience in the pharmaceutical industry in the areas of QA, QC and production of biotechnologically produced active ingredients, including contract manufacturing.
If you want to benefit from my experience, give me a call. I'm ready.
Together we will find tailor-made solutions for you and your company.
„30 years of professional experience in the pharmaceutical industry, including 20+ years in management.“
Special focuses
- Interim management
- Authority management (incl. inspections – FDA, EDQM, PMDA, kFDA, local surveillance authority)
- External audits (ca. 100 performed)
- Supplier management
- Validation, qualification
- Cleaning validation
- Raw material testing
- Employee qualification, training, elearning
- CMO management, quality agreements
- Deviations
- Change control
- CAPAs
- Quality risk management
- Management reviews, PQR
- Internal audits
- Environment, health and occupational safety
