Quality Assurance expert in Pharmaceuticals and Medical Devices with background as Research and Analytical Chemist. - Management of Quality Systems in GMP environment- Hosting of Drug GMP inspections, and Medical Device inspections from Regulatory Authorities- Preparation and review of GMP technical documentation- Investigation of deviations, Non-conformances and Out of Specification (OOS) results- Internal audits, Corrective and Preventive Actions (CAPA)- Product release; Product Quality Review; New products- Change control; Process /product change, Process improvement, - Packaging /Labeling, Importation, Distribution- GMP trainingRegulatory Affairs experience in Pharmaceuticals and Medical Devices, from new drug /new Medical Device submissions to pharmacovigilance,Specialties:- Quality Systems in GMP environment- Product quality complaints - Drug product stability- Quality Control and Research Lab, analytical and instrumental chemistry- Lab techniques including Chromatography, Spectroscopy, etc- Chromatography Data Systems (CDS); Lab Information Management System (LIMS); Systems, Applications and Products (SAP),