Senior Quality Consultant
Profile Last Update:
Auditor Profile
Senior Quality Consultant
Country
Germany
Education
Highest Educational Qualification
Masters Degree
Masters Degree
Language(s)
GermanNative
RussianNative
EnglishProfessional
FrenchElementary
Regulatory Framework
| EU Regulation | |
| US Regulation | |
| Japanese Regulation | |
| Rest of the World |
Auditing Experience
11 Years
Availability Time
Not Available for Hire
Number of Audits performed in the Last 3 Years
As Lead AuditorUp to 15
As Co-Auditor15 to 30
Number of Audits per Category performed in the Last 3 Years
| Investigator Sites | 20 | 62.5% |
| Sponsor System or Process Audits | 2 | 6.25% |
| Clinical Laboratory Audits (Central/Safety) | 3 | 9.38% |
| Clinical Laboratory Audits (Biomarker, PK/PD) | 1 | 3.13% |
| Investigational Medicinal Product Audit (GMP for IMP) | 0 | 0% |
| Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) | 3 | 9.38% |
| Vendor/CRO (Full or Part service) | 3 | 9.38% |
| For Cause Audits | 0 | 0% |
| Pharmaceutical Product: Chemical | Current Practice |
| Pharmaceutical Product: Biological | Current Practice |
| Adv. Therapy Medicinal Products | Not Applicable |
| Medical Devices | Previous History |
| Consumer Products | Previous History |
| Cosmetic Products | Not Applicable |
| Food Stuffs | Not Applicable |
| Industrial Chemicals | Not Applicable |
| Investigator Site Audits | Current Practice |
| Sponsor System or Process Audits | Current Practice |
| Clinical Laboratory Audits (Central/Safety) | Current Practice |
| Clinical Laboratory Audit (Biomarker, PK/PD) | Previous History |
| Investigational Medicinal Product Audit (GMP for IMP) | Not Applicable |
| Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) | Current Practice |
| Vendor/CRO (Full or Part Services) | Current Practice |
| Due Diligence/For Cause Audit | Previous History |