Michael Jarosch
Principal Consultant Gmp Qualitäts- & Labor-compliance (Fda Eu Ich) Reinigung & Validierung at Gempex Gmbh
Based in Mannheim, Germany
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Seniority
Other
Department
Other
Location
Mannheim
Industry
Pharmaceutical Manufacturing
Company size
49
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m•••••••@gempex.com
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Background
About Michael Jarosch
30+ Jahre Erfahrung in GMP-Compliance – von Wirkstoffen und Hilfsstoffen über Formulierungen bis hin zu Laboren und aseptischer Produktion. Als Principal Consultant bei gempex unterstütze ich Hersteller bei Inspektionsvorbereitung, Qualifizierung & Validierung, Data Integrity, Annex-1-Compliance sowie Cleaning Validation. Mein Fokus: praxisnahe Lösungen, die Audit-sicher sind und gleichzeitig die betrieblichen Abläufe nicht blockieren. Ich biete Workshops, GAP-Analysen, Inspektions-Coaching und begleite Unternehmen auf dem Weg zu Zero Findings bei FDA- und EU-Audits. Kernkompetenzen: • GMP-Inspektionen & Audits (FDA / EU / ICH) • Annex 1 & Aseptik • Methoden- & Cleaning Validation • Data Integrity & Labor-Compliance • Change Management & Training With 30+ years of experience in GMP compliance, I support pharmaceutical and excipient manufacturers in achieving inspection readiness, qualification & validation, data integrity, Annex 1 compliance, and cleaning validation. As Principal Consultant at gempex, my focus is on practical, audit-proof solutions that safeguard compliance without blocking operations. I provide workshops, gap assessments, inspection coaching, and guide organizations toward zero findings in FDA and EU audits. Core competencies: • GMP inspections & audits (FDA / EU / ICH) • Annex 1 & aseptic manufacturing • Method & cleaning validation • Data integrity & lab compliance • Change management & training
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