Israel Duarte Email & Phone Number

Quality Operation Director

Panama

I established strategies in Latin America to ensure the registration of new products and the maintenance of the portfolio to increase the access of products to the regions according to the business plan.• Aligning strategies between local marketing and regional marketing, ensuring the process of sanitary registration of agreed products in each country.• Coordinating the Regulatory Affairs team across Latin America, made up of the regional regulatory team and the dossier creation team based in Colombia, establishing a line of work to avoid interruptions in the registration process.

Area Panama Pacifico

I managed the Quality Management System promoting compliance and driving a cultural change of the organization towards compliance in quality issues.• Influencing my team in the search for continuous improvement of the SGC through internal audits, KPI´s, analysis of non-conformities and development of corrective and preventive action plans.• Promoting compliance with activities required by the regulations of the countries under the scope of the position (technovigilance, claims management, inspections by local authorities).• Strategically and technically supporting the implementation and modification of quality management systems, new facilities and new processes, to ensure business continuity by promoting compliance with corporate policies and GMP and GSP requirements.• Reporting KPI´s and other metrics to LATAM QA management.

Panama

I implemented Quality Management Systems and established control processes for local warehousing operations in Panama and Costa Rica as well as for distributors.• I successfully established three quality management systems, ensuring compliance with Medtronic's corporate policies.• I coordinated the creation of the secondary labeling process for medical devices, as well as the construction of an area for the execution of this process (development of documentation, and controls required by local corporate and regulatory policies for Panama and Costa Rica).• I implemented the complaint handling processes, as well as product retention processes, recall, BPD, among others, positively impacting the response time of claims, as well as the control of non-compliant products.• I promoted the creation of procedures for other areas to ensure the standardization of their processes in accordance with corporate policies.

Panama

To develop strategic plans to assure time compliance on the production orders, implemented SOP ans local laws.• I established strategies to ensure compliance with procedures and order delivery times.• I led the production strategy, improving the delivery times of the main client from 30% to 93%.• I developed support documentation, procedures, instructions and flows for use in the process of work orders in the area.• I implemented with the customer service department a process to evaluate priorities according to customer needs, ensuring timely delivery of products according to the production plan.

Panama

• Lead the logistics of work in the plant, maintaining the established levels of productivity complying with the required product specifications.• Manage the KPI's of the area and report it to general management, receive corporate and official audits, establishment of CAPA's. and personnel management (2 supervisors and 38 operators)

Panama

Develop the following activities on the floor:• Carry out the control of the conditioning process, review of production orders to give a final opinion, reception of claims and addressing to the manufacturing plants.• Measurement and report of KPI's of the Quality department at the end of each month.• Assist in corporate and official audits and support in the root cause analysis in the CAPA process.

Master In Pharmaceutical Sciences, Quality Control Medicines

Licenciado En Derecho Y Ciencias Politicas

Bachelor In Pharmacy (B.Pharm.)

Bachelor'S Degree, Science

Education record