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QA Expert Operations
hace 2 semanas
Major Accountabilities
~ Mantiene los Procedimientos Operativos Estándar (SOP) aplicables, la documentación que cumple con las Buenas Prácticas y los registros dentro del Sistema de Gestión de Calidad de Novartis.
~ Asegura la integridad de todos los registros y datos de los Sistemas de Calidad, según corresponda y la colaboración del propio equipo con otras funciones y departamentos.
~ Asegura un nivel adecuado de educación, conocimiento de GxP
~ Actualiza y mantiene la información relevante en los sistemas electrónicos (por ejemplo, control de cambios, documentación, quejas y manejo de proveedores)
~ Seguimiento y monitoreo de, por ejemplo, CAPA, acciones, métricas, plan de calidad)
~ Apoya las auditorías de calidad y las inspecciones de las autoridades sanitarias
~ Notificación de reclamaciones técnicas/eventos adversos/escenarios de casos especiales relacionados con los productos Novartis en un plazo de 24 horas a partir de su recepción
Key Performance Indicators
~ Apoya todas las actividades de GxP en el departamento de Calidad.
~ Administra los Sistemas/Procesos de Calidad incluyendo documentación, métricas y seguimiento de acciones.
~ Realiza actividades operativas y de cumplimiento de GxP de acuerdo con los estándares de calidad de Novartis.
~Contribuye a proyectos e iniciativas de calidad.
Work Experience
~Amplitud funcional
Skills
~Sistemas de Gestión de la Calidad (SGC)
~Gxp
~Estándar de la industria
~Requisitos de cumplimiento
~Estándares de calidad
~Lidiar con la ambigüedad
~Conciencia de sí mismo
~Aprendizaje continuo
~Experiencia tecnológica
Language
Inglés
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Division Operations
Business Unit Pharmaceuticals
Location Mexico
Site INSURGENTES
Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
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