Dr. Viktoria Krongardt -Kamann

www.helvetic-medical.ch and www.qs-qk-service.com

www.qs-qk-service.com Tasks Quality Assurance Senior Manager and Qualified Person oder Sachkundige Person and Verantwortlicher Person für GDP / Logistik/ Supply Chain/ Transport und Qualified Person Pharmacovigilance QPPV und Betäubungsmittel Beauftragter

Lead Investigatior, Lead Auditor, Senior Quality Manager ( Manufacturing, Labor, CSV, Technik, Engineering)

www.qs-qk -service.de

 Quality Management System (QMS)  Deviation Management  Analysis and Testing (GCLP)  Investigational Medicinal Products (CT -Clinical Trial and GCP)  Pharmaceutical Packaging  STARLIMS/LIMS  Risk Assessment  Law and Administration (2001/83/EC and 2001/82/EC/ ICH/PIC/Japan/Brazil/China/ USA/EU)  Active Pharmaceutical Ingredients and Excipients (Law)  Clinical Trials  QA /QC  QMC/KPI  CAPA  Supply Chain  Isolator Technology  CMO

 Technical, administrative and personal management of the Quality Control Laboratory  Organization of the release of raw materials, intermediates and finished products  Deputy of Qualified Person  Responsible for the QC release of packaging and raw materials, intermediate, bulk and finished products

 Organization Quality Control  Organization Microbiology  Organization Management  Environmental Monitoring  OOS/CAPA/Deviation  Qualification and Validation  Analysis and Testing  SOPs

Teambildund, Konflikt Lösung, Motivation, Personal Entwicklung

Pharma, Medizinprodukte Qualified Person

Managementkompetent und sozialekompetenz in der Pharma Industrie

Mikrobiologie, Biochemie