Vimarie Ortiz

20 years of experience in successful implementations of global, regional and national ERP and system application projects, providing solutions in multicultural and cross-functional team environments. Technical, software quality and business background with strong experience in the pharmaceutical industry. My strengths among others include: • Excellent communication and writing skills, problem analysis and resolution, system test plans and strategies, software testing metrics development and analysis, and test activities through all cycles. • Experience leading and collaborating with geographically dispersed teams (Europe, North, South, and Central America, and India) in software quality assurance activities through all stages of system development, release and changes • Map, and improve business and technical procedures to ensure compliance with business and regulatory requirements, including change and documentation control. • Technical Training • Fully bilingual, Spanish and English; some Italian SPECIALTIES Software Quality Documentation and Specifications, Manual/Functional testing, Automation testing (HP Quality Center, HP Application Lifecycle Management), Systems Development Life Cycle (SDLC), Systems Test Cycles, Defect Tracking and Management, Document management/collaboration tools (Microsoft SharePoint Services), QA document Management (Documentum, TeamCenter), QA Activities Management (TrackWise), UDI System (Informatica MDM) Software Quality Engineering, Business Analysis, Training Development and Delivery, Computer Systems FDA regulations (FDRs, GxP), Computer Systems Validation (CSV) and Change Control (CC), Data Migration Validation, 21 CFR Part 11, Annex 11, Mexican Regulation for Computer Systems, GAMP 5, Requirements Management, Risk Management, Configuration Management, Windows Office Applications, JDE OneWorld Xe and EnterpriseOne Infrastructure and Applications validation, Global Trade System (GTS), Camstar MES System, Visio, HP DSI dcLINK validation, Acrobat Writer, Master Control Documentation Manager, Lotus Notes, SAP , EtQ QMS Solutions, Windchill System, DCMS, Denali Citra, Wonderware Systems, IT IQ, OQ, PQ.