I’ve been working since more than 15 years in the field of medical devices, pharmaceutical, biotechnological as well as phytopharmaceutical industries.
I gained my experience in big as well as medium – sized companies. My field of work ranged from management representative (ISO 13485 and 21 CFR 820) and the maintaining of the quality management system, complaint management as well as the certification of medical devices and as head of the quality control.
Since spring 2011 I work as a freelancer for consulting and auditing.
Amongst others (examples) I aquired the following qualifications:
FDA’s cGMP for Finished Pharmaceuticals
FDA’s cGMP for Medical Devices
Medical Device Regulatory Affiars
DGQ – Qualitätsbeauftragte und interner Auditor
DGQ – Auditor Qualität