Profile: Proficient, results–focused expert with 10+ years of experience in pharmaceutical industry in the areas of Quality/ GxP, Supplier Qualification, CSV, and audit. Creative, flexible, communicative, talented and agile. Motivated and multitasking. Quality skillful and accomplished regarding EU regulatory affairs such as Quality system requirements, CTD, Inspections, Quality Risk Management, CAPA Handling and Change Management. Proven history in quality auditing of manufacturing sites including production, QA,QC, warehouse and technical engineering departments and also quality reviewing of conceptual design of manufacturing sites. Have considerable experience regarding GMP auditing in different companies and countries according to the EU regulations. For audit services, prefer European countries and also Iran. But have no problem to go to the other countries, other than those who are in internal or external war. Language expertise: fluent in English, have basic knowledge in German, mother language is Persian and know a little bit Arabic. Based in Austria.
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