Quality Operations Specialist
hace 3 semanas
**Summary**:
~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.
**About the Role**:
Major Accountabilities
~ 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
~ Rev. de MBR
~ 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
Key Performance Indicators
~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.
Work Experience
~QC/ QA en industria farmacéutica / biotecnología con control medioambiental y zonas limpias
~Amplitud funcional
~Colaboración internacional
**Skills**:
~Inteligencia Tecnológica
~QA (Aseguramiento de la Calidad)
~Procedimientos GMP
~Estándares de calidad
~Pruebas de control de calidad (QC)
~Lidiar con la ambigüedad
~Conciencia de sí mismo
~Aprendizaje continuo
~Experiência tecnológica
Language
Inglés y Español. Portugués deseable
Division
Operations
Business Unit
Innovative Medicines
Location
Chile
Site
Santiago
Company / Legal Entity
CL01 (FCRS = CL001) Novartis Chile S.A.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
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