Quality Operations Specialist
hace 2 semanas
Job Description Summary
Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
Job Description
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
- Experiencia tecnológica
Language:
Inglés y Español. Portugués deseable.
Skills Desired:
Continued Learning, Dealing With Ambiguity, GMP Procedures, QA (Quality Assurance), Quality Control (QC) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence.
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