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El puesto tendrá las siguientes responsabilidades: Realización de ensayos farmacotécnico\n \nDesarrollo de métodos de elaboración\n \nFabricación de lotes piloto.\n \nConfección de informes de desarrollo de productos.\n \nConfección de documentación de fabricación (métodos y registros de fabricación).\n \nControl de elaboración de lotes productivos.\n \nConfección de protocolos de validación de procesos y transferencia de tecnología.\n \nParticipación de validaciones de proceso\n \n \n\nSomos una empresa farmacéutica regional con base en Argentina comprometida con la excelencia y la mejora continua: desarrollamos y producimos medicamentos de calidad con valor humano agregado.\n \n \n\nCompartimos la visión de un mundo donde la salud no sea un privilegio. 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Reduciendo las emisiones nocivas. Otorgando propiedades únicas a aplicaciones de alta gama. Dando nueva vida a los metales usados. Somos la empresa líder en tecnología de materiales circulares que cumple su misión de crear materiales para una vida mejor.\n\n \n\n\n**Acerca del Negocio**\n\n\n\nQuímica que mejora la vida. Umicore es experto en catálisis basada en metales para aplicaciones que mejoran nuestra calidad de vida. Tecnologías de tratamiento de emisiones automotrices, ingredientes farmacéuticos activos para tratamientos contra el cáncer, la producción de productos químicos finos y electrónica avanzada: todo esto es posible gracias a nuestra experiencia en tecnología organometálica. Para llevar la magia de la química y la catálisis basadas en metales a nuevos clientes y nuevas aplicaciones, no podemos quedarnos de brazos cruzados. Necesitamos encontrar nuevas maneras de hacer las cosas, descubrir nuevas soluciones y desarrollar nuevas ideas. Y ahí es donde usted entra en escena.\n\n \n\n\n**Qué funciones llevará a cabo**\n\n\n* Asistir a Garantía de Calidad en la recepción de inspecciones y auditorias nacionales e internacionales.\n* Participar activamente en la generación, revisión y aprobación de documentación referida a los sistemas de calidad del área de incumbencia.\n* Realizar y gestionar la realización de los monitoreos de servicios críticos (aire y agua), como así también el seguimiento de las conductas higiénicas y tendencias microbiológicas de las áreas productivas y el personal operativo.\n* Realizar las investigaciones surgidas a partir de Desvíos u OOS detectados en la planta de elaboración de APIs.\n* Colaborar en la realización de auditorías internas y a proveedores.\n* Administrar los recursos del laboratorio de Microbiología, de manera de satisfacer las necesidades de Producción y Garantía de Calidad.\n* Colaborar en la respuesta a los reclamos de clientes.\n* Formar parte de los equipos de validación para la calificación de equipos, servicios, instalaciones, procesos, metodologías analíticas y procedimientos en general.\n* Gestionar la compra, utilización y manejo de los materiales y estándares utilizados.\n* Emitir y revisar documentación del área. 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