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Regulatory Affairs Specialist

hace 2 meses

Colombia Essity A tiempo completo

Nombre del cargo: Regulatory Affairs Specialist

Acerca del rol:

Gestionar, dirigir y controlar los recursos de Gestión de calidad, asegurando que se lleven a cabo todas las actividades necesarias para garantizar la óptima calidad y seguridad de los productos de la compañía de acuerdo con las especificaciones establecidas de forma que satisfagan las necesidades y expectativas nuestros clientes.

Desarrollar las actividades necesarias desde el punto de vista técnico – legal ante entidades gubernamentales Nacionales, filiales Essity y clientes, para los lanzamientos de nuevos productos (Fabricados por el PC e Importados). Asegurando el cumplimiento de la normatividad legal vigente en Colombia para la comercialización de Dispositivos médicos fabricados e importados.

Que harás:

  • Representar técnicamente a la Compañía ante el INVIMA.
  • Asegurar que el personal del laboratorio tenga la competencia necesaria para las funciones requeridas y sus calificaciones reflejen sus responsabilidades.
  • Planificar y gestionar los recursos necesarios para el funcionamiento adecuado del laboratorio de calidad y del sistema de gestión de Calidad.
  • Oficial de Seguridad (Safety Officer) de la compañía, responsable de la seguridad y eficacia de los productos.
  • Asegurar que los productos fabricados cumplan con los requerimientos legales y realizar la liberación de materias primas y producto terminado.
  • Responsable de la gestión de riesgo de productos fabricados por la compañía.
  • Asegurar que los Productos Fabricados se encuentren almacenados en las condiciones establecidas y cumplan con los requerimientos legales.
  • Responsable del control y vigencia de los documentos Regulatorios para el funcionamiento de la compañía además de la aplicación de los requeridos establecidos en las normas ISO 13485, ISO 14001, INVIMA aplicables a su proceso.
  • Proponer, planear y coordinar actividades de mejoramiento continuo en los procesos productivos, proveedores, materiales, etc., de forma que se mantenga la competitividad de nuestros productos.
  • Planear y dirigir la inspección en planta de los productos de la compañía.
  • Revisar, definir y aprobar el plan maestro anual de validación con el comité directivo de validación. Revisar y aprobar los informes de las validaciones ejecutadas.
  • Planear y dirigir los análisis que permitan efectuar la evaluación de quejas y reclamos hechos por los clientes.
  • Verificar el cumplimiento del programa de garantía de calidad.
  • Evaluación estadística y análisis de datos.
  • Asegurar, planear y coordinar el Mantenimiento del Sistema de Gestión de Calidad de acuerdo a las normas ISO 13485.

A quién buscamos:

  • Estudios: Profesional en Bioquímica, Química, Química farmacéutica o áreas afines.
  • Experiencia: de 4 años en cargos similares en un laboratorio de calidad de productos farmacéuticos en el sector textil o en la industria.
  • Conocimientos básicos indispensables:
  • Conocimientos en sistemas de información (Windows, Word, Excel, Power Point, SAP- deseable).
  • Conocimientos de las normas, ISO 13485, ISO 14001, FDA, MDR y requisitos aplicables a la organización de BPM de acuerdo al informe 32.
  • Formación Académica Aseguramiento de la calidad (especialización, seminarios, diplomados o cursos).
  • Habilidades blandas deseadas: trabajo en equipo, toma de decisiones, comunicación efectiva, orientación a resultados, innovación y mejoramiento continuo.
  • Nivel de inglés: Mínimo B2.

Que te ofrece nuestra Compañía:

Somos una Compañía Multinacional Sueca, líder global en soluciones para mejorar el bienestar de las personas en Higiene y Salud.

Estamos orientados a obtener resultados superiores, dentro de una cultura de cuidado por las personas, liderazgo y colaboración. En nuestra Compañía creemos que cada carrera es tan única como la persona y que los colaboradores pueden alcanzar su máximo potencial en una cultura ganadora, motivada por un propósito poderoso. Ofrecemos un ambiente de trabajo colaborativo y solidario, Empoderamiento, Impacto del trabajo, Trabajar con un propósito poderoso, Aprendizaje y desarrollo individual, Salud y seguridad, Responsabilidad social e Innovación.

Si te identificas con este desafío, postúlate ahora mismo.

Lugar de trabajo: Funza – Cundinamarca, Colombia

Application End Date:

07 nov 2024

Job Requisition ID:

Essity247755

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