Quality Operations Specialist
hace 6 días
Descripción del empleo
- Soporte en la preparación y liberación de lotes en la región Américas
- Ejecución de actividades locales que soporten a la liberación de lotes como revisión de temperatura de transporte, interacción con autoridad sanitaria, gestión de retornos, etc.
- Soporte en proyectos de mejora de OpEx
Persona Calificada:
- Ejecuta el lanzamiento de lotes cumpliendo con la registración
- Notificación de quejas técnicas / eventos adversos / escenarios de casos especiales relacionados con los productos Novartis dentro de las 24 horas posteriores a la recepción
- Gestiona aspectos de Calidad y proyectos dentro del área de responsabilidad.
- Garantiza y respalda la conformidad general de GxP y el cumplimiento de los sistemas de gestión de calidad de Novartis.
- Experiencia en QC/QA en industria farmacéutica/biotecnología con control medioambiental y zonas limpias
- Colaboración internacional
- Inteligencia Tecnológica
- Conocimiento de procedimientos GMP y estándares de calidad
- Pruebas de control de calidad (QC)
- Lidiar con la ambigüedad
- Conciencia de sí mismo
- Experiencia tecnológica
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