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Summary A Quality Assurance leader with 25+ years of cGXP expertise working in the Biotech and Commercial Pharma manufacturing industry. Extensive experience working directly with USA and EU CMOs/CTLs dealing with process drug development/ process troubleshooting, process validation, inspection readiness, and IMP distribution/ disposition. Successful FDA/EMA/ROW inspections and approval history with expertise leading global...
PROFILE * Strong background in Quality Assurance / Quality Control procedures with15 plus years of experience in the pharmaceutical and the biotech industry. * Experience in medical device, manufacturing, QC Lab, regulatory/QA functions in pharmaceutical, biologics sterile product manufacturing facility. Strong working knowledge of GMP, GLP, GCP, ICH & ISO guidelines. Excellent written, oral communication, organizational an...
Tags for this Online Resume: biotech, quality, pharmaceutical, assurance, regulatory, biotechnology, batch, validation, control, review, document, change, protocol, deviation, capa, management, manager, specialist, release, GMP
SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...
Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL