Quality Assurance Coordinator

hace 1 semana


Buenos Aires, Buenos Aires C.F., Argentina Doctasrh A tiempo completo

Buenos Aires - hace un día
Descripción de la vacante
Abbott se encuentra en búsqueda de un Coordinador de Aseguramiento de Calidad y Director Técnico para su División relacionada con equipamiento diagnóstico.
Principales Responsabilidades del rolReferidas al Sistema de Calidad - Realizar una adecuada interpretación de los requerimientos normativos y de las políticas matriciales de Abbott, y garantizar el cumplimiento continuo de dichas disposiciones.Actuar como co-Director Técnico ante ANMAT y como Director Técnico ante el Ministerio de Salud de la Provincia de Buenos Aires para el depósito habilitado.Referidas a la Auditoría Externa - Recibir los auditores externos o inspectores de las autoridades sanitarias nacionales o de la provincia, en atención de los requerimientos aplicables.Realizar la notificación correspondiente sobre la auditoría externa que se recibe.Referidas al Almacenamiento y Acondicionamiento de Productos Médico - Supervisar la cadena de suministro inbound y outbound para asegurar la calidad de los productos médicos distribuidos por la afiliada.Revisar y aprobar los procedimientos e instructivos relacionados con las operaciones de almacenamiento, acondicionamiento y distribución.Realizar entrenamientos rutinarios al personal de la afiliada y del operador logístico en los procedimientos vigentes.Gestionar y comunicar las desviaciones de temperatura, aprobar o rechazar los productos recibidos en el depósito, con base en la inspección realizada de manera presencial o con soporte del checker.Comunicar las disposiciones finales de destrucción de productos y realizar la aprobación de estas en el memo generado por Operaciones.Referidas a la Vigilancia Post-mercadeo - Reportar de manera oportuna las acciones de campo correspondientes a la agencia sanitaria, reportando de manera oportuna las comunicaciones de calidad y acciones de campo a los clientes.Brindar apoyo en las respuestas a quejas y reclamos de clientes y usuarios.Registrar, analizar y gestionar todo efecto indeseado causado por producto médico, recomendando las medidas preventivas y correctivas adecuadas.Conocimientos, Educación y ExperienciaNos orientamos a un profesional Farmacéutico con experiencia comprobable en las actividades especificadas arriba, ejercida en la industria de medical devices, farmacéutica o similar.
Manejo intermedio/avanzado de idioma inglés.
Se ofrecen condiciones de contratación interesantes, y las oportunidades de desarrollo que una compañía de la envergadura de Abbott puede ofrecer.

#J-18808-Ljbffr



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