Mayra Alejandra Ramírez Gómez Email & Phone Number

Pharmacist from National University of Colombia. MBA from EUDE Business Schoool/Universidad Camilo José Cela. FPX Project Management Leader. Responsible, creative, committed to excellence and customers post sale experience, persistent to achieve goals, open to learning, dynamic person, qualified to lead projects and processes, highly achievement-oriented and strategic thinker. Eleven (11) professional years of experience: Technical areas of Quality Assurance/Regulatory Affairs in the Pharmaceutical Industry and Medical Devices. Emphasis on Risk assessment evaluation, Field Actions (Recall, Stop Shipment, Field Safety Notifications), Quality control importation processes, Product Complaint Management, Leadership of Audit (Internal/External) processes, CAPA Management, Coordination of Repack and Relabel operations, Purchasing control (suppliers and distributors), Coordination of quality activities in 3PL/Distributors sites, Change control process, Support to local HEalth Authority inspections and Quality Management System. Also, I have extensive relationship with multidisciplinary teams, Trade associations and regulatory agencies to ensure regulatory plan and projects execution according to priorities. In-depth knowledge of the Colombian Health System (GMP, GPL, GDP, ICH), and regulations in force.High personal accountability, proactive and problem-solving skills.Strong interpersonal skills and networking capabilities to establish relationships and lead form working groups, easy communication and teamwork. Proficiency in software packages such as; Microsoft Windows package, MS Office (Excel, Project, Planner, Word, PowerPoint), SAP, Trackwise, ECM, among others.Fluent English and Spanish languages.

Listed skills include Microsoft Office, Microsoft Excel, Microsoft Powerpoint, Quality Assurance, and 1 others.