- Realizar una adecuada interpretación de los requerimientos normativos y de las políticas matriciales de Abbott, y garantiza el cumplimiento continuo de dichas disposiciones.
- Actúa 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.
- Recibir los auditores externos o inspectores de las autoridades sanitarias nacionales o de la provincia, en atención de los requerimientos aplicables
- Realiza la notificación correspondiente sobre la auditoría externa que se recibe
- Supervisa la cadena de suministro inbound y outbound para asegurar la calidad de los productos médicos distribuidos por la afiliada.
- Revisa y aprueba los procedimientos e instructivos relacionados con las operaciones almacenamiento, acondicionamiento y distribución.
- Realiza entrenamientos rutinarios al personal de la afiliada y del operador logístico en los procedimientos vigentes.
- Gestiona y comunica las desviaciones de temperatura, aprueba o rechaza los productos recibidos en el depósito, con base en la inspección realizada de manera presencial, o con soporte del checker.
- Comunica las Disposiciones finales de destrucción de productos y realizar la aprobación de estas en el memo generado por Operaciones.
- Reporta de manera oportuna las acciones de campo correspondiente a la agencia sanitaria, reportando de manera oportuna las comunicaciones de calidad y acciones de campo a los clientes.
- Brinda apoyo en las respuestas a quejas y reclamos de clientes y usuarios.
- Registrar, analizar y gestionar todo efecto indeseado causado por producto medico, recomendando las medidas preventivas y correctivas adecuadas.
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Quality Assurance Coordinator - Buenos Aires, Argentina - Abbott
hace 1 semana
Descripción
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 rol:
Referidas al Sistema de Calidad
Referidas a la Auditoría Externa
Referidas al Almacenamiento y Acondicionamiento de Productos Médico
Referidas a la Vigilancia Post-mercadeo
Conocimientos, Educación y Experiencia
rofesional 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.
