Quality Operations Specialist

hace 2 semanas


Santiago de Chile Novartis A tiempo completo

**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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