Marco Cotoia
Direttore Tecnico - Site Quality Assurance @CEVA Logistics
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WORK HISTORY
Direttore Tecnico - Site Quality Assurance @CEVA Logistics
Main duties- Batch record review in compliance with cGMP - Secondary packaging activity management cGMP compliance- Quarantine material storage (finished products and APIs)- Guarantee the implementation, the maintenance and improvement of the Quality Management System- Sets targets for SOPs, relating to GDP( Good Distribution Practice) and cGMP (Good Manufacturing Practices)- Provide recommendations for corrective actions;Track CAPAs until closure;Follow up to ensure CAPAs and Change Controls are effective- Relations management with Italian Authorities (AIFA, Ministry of Health)- Supplier\' Audits & Self inspections - Trainings management- Requalifications and Revalidations Management of equipments, processes and softwares- Strong knowledge of warehouse management softwares : WMS Matrix,SAP.
EDUCATION
Università degli Studi 'Gabriele d'Annunzio' di Chieti
Master degree in Pharmacy and Industrial Pharmacy
Università degli Studi 'Gabriele d'Annunzio' di Chieti
Qualified as Pharmacist
SKILLS
ABOUT MARCO COTOIA
Strong Knowledge of Quality Management System (GDP / GMP / ISO compliant), expertise in Pharmaceutical field: logistic/ production.( QA Operations, Systems and Compliance, Auditing, Data Integrity). I help to solve and prevent compliance gaps/problems to assure products with safety, quality and efficacy standards at patients.
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