Profile: Coordinated 25+ GMP regulatory inspections as FDA, ANVISA and different European health authorities. Redesigned and implemented over 15 business processes for an estimated 30% efficiency gain in operations and potential net savings of 5M€. Performed 100+ GMP, GLP and GDP audits in Europe, Asia and America. Managed international cross-functional (external & internal) teams to implement 10+ product transfers. Identified and analyzed 15+ new Quality Metrics which led to increased visibility and Quality Culture major improvements. 14+ years of GxP Leadership, ISPE Member ¦PDA Member. IRCA Certified Pharmaceutical GMP Auditor Training (NSF Pharma Biotech Consulting). Green Belt Certification (Operational Excellence in Making Medicine Novartis). Based in Valencia (Spain).Audit in Europe and sometimes also travel to other continents as Asia (Vietnam, China) depending on customer needs. Language expertise: Spanish, English, German speaker.
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