Cologne Bonn Region
Executive Summary: Solution-oriented, pragmatic, technical and commercial professional with over 30 year experience in international pharmaceutical business and industry. Responsibilities in quality-, manufacturing- and supply chain operations for generics, originals, OTC, biotecs, investigational medicinal products, herbals with international background in relevant businesses and regulations. Leading contract manufacturing, auditing and accredited qualified person in accordance to EU-GMP. Core competences in IT system design for pharmaceutical industry. Leadership competencies since 25 years in leading multinational teams. Close relationship management with international agencies like EMA, MHRA, TGA, HPRA, BfArM, FDA, ASNM, NMDA etc. Fluent in German and English, knowledge in French and Spanish.
Current Projects with: - Viatris - Kyowa Kirin Pharmaceutical Consultancy in Quality Operations - Independent EU QP service - Quality Management Systems - Experience in dossage forms, sterile, lyophilisation, solid dossage forms, semi solid dossage forms, liquids, herbal extracts inclusive cannabis, biotecs, biosimilars. - Audits of Manufacturers (API, Sterile-, Non-Sterile DFs, Excipients, Packing Materials) - Root Cause Investigation and CAPA Efficiency - Remediation of Inspection Findings (GMP- Non-Compliance, 483, WL, CD) - Organisation and Reorganisation of Quality Department Strucures - Communication and inspections with International Agencies (FDA, WHO, Health Canada, ANSM, TGA, MHRA, HPRA, ANVISA, BfArM, Infarmed, Swiss Medic etc.)
QMS / QA Project for obtaining Import Licences, Narcotic Licence and Wholesaler Dealers Licence for medical Cannabis flowers and extracts. Consulting on herbal medicinal products manufacturing, quality control, quality assurance, quality management and regulatory compliance . Operational responsibility for timely batch certification and batch release. Communication with Health Authorities and Narcotic Agency.
-Excom member (Vorstand) for international Quality Operations. -Interaction with international agencies -Budget responsibility for 45 sites and 1600+ employees -Leading continuous improvement process
Leading the quality operations of 15 legal entities of Ranbaxy including 5 manufacturing sites in UK, Ireland, South Africa, Nigeria, Morocco. Offices in Egypt, Ukraine, Russia, Spain, Poland, France, Germany, Romania and rep office in Lithuania Baltics. Approximately 270 reports and handling 10000 + batches of almost all dossage forms including injectables and patches.
Leading the quality operations of 8 legal entities of Ranbaxy including 2 manufacturing sites in UK, Ireland, Spain, Portugal, Poland, France, Germany, Romania, and rep office in Lithuania Baltics. Approximately 160 reports and handling 7000 + batches of almost all dossage forms including injectables and patches.
Leading the Quality operations of the German business operations of Ranbaxy Laboratories Ltd. Acting as senior qualified person.