Complaint Process Analyst I
hace 3 semanas
- External
OBJETIVO DE LA POSICION:
Trabajar en la organización global de calidad de AbbVie procesando quejas y consultas sobre productos farmacéuticos, dispositivos médicos/vigilancia y productos combinados.
Dicha posición requiere constante interacción con clientes internos y externos de AbbVie tales como médicos, enfermeros, farmacéuticos, personal de hospitales, gestores de riesgos, agentes de compras, representantes de ventas, público en general, centros de fabricación, soporte técnico, organización comercial en relación con las quejas de productos de AbbVie.
RESPONSABILIDADES CLAVE:
% DEL TIEMPO O:
IMPORTANCIA:
Garantizar que los registros de quejas cumplen con los requisitos globales
20%
Asegurar la correcta documentación del producto, investigación y revisión de todas las quejas no médicas como también médicas que involucren un evento no relacionado con la calidad médica.
Proporcionar un servicio de calidad al cliente a través de la coordinación de las muestras retornadas para su investigación, las actividades de seguimiento como la sustitución del producto, la categorización de las quejas y el CAPA.
Asegurar que la documentación de las quejas cumple con las buenas prácticas de documentación, así como con los GMP (_Good Manufacturing Practice_) y GCP (_Good Clinical Practice_).
N/A
Identificar los eventos potencialmente reportables y notificar a los grupos funcionales y dirección correspondiente.
20%
Ser el punto de contacto con terceros fabricantes (_Third Party Manufacturers_), profesionales de la salud, público en general, clientes internos, áreas funcionales de AbbVie y agencias regulatorias
20%
Incluir la creación y la presentación de informes regulatorios, las comunicaciones con los clientes, los organismos regulatorios y con diversos terceros (Third parties).
Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos.
10%
Cumplir con todas las políticas y lineamientos de la compañía.
N/A
Todas las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato.
N/A
Qualifications
External
Educación y Experiência
Bachiller universitario en carreras tecnológicas, ingeniería, o con algún enfoque científico (Técnico de Laboratorio Médico o enfermería certificada) o +1 de experiência laboral relevante.
Otras habilidades profesionales:
Capacidad de análisis, redacción técnica y buena documentación.
Capacidad para priorizar múltiples proyectos para garantizar el cumplimiento de la regulación y los procedimientos operativos estándar.
Habilidad para trabajar con equipos multifuncionales y para interactuar eficazmente con los compañeros, la dirección y los clientes.
Conocimiento Técnico:
Conocimientos de regulación federal FDA (21 CFR 803, 820) y reglamentos de reportabilidad de dispositivos médicos
Preferencia
Conocimiento de requerimientos regulatorios globales de productos farmacéuticos, dispositivos médicos o productos combo. Norma de gestión de sistema de calidad para dispositivos médicos (ISO 13485)
Preferencia
Habilidades:
Técnicas
N/A
Idiomas
Conocimiento del idioma inglés (obligatorio).
Cómputo
Facilidad para el trabajo con programas en ambiente Windows, tales como Word, Excel y Power Point (obligatorio).
Preferible conocimiento en manejo de sistemas de quejas (opcional).
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