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Quality Assurance Specialist
hace 2 meses
**Job Summary**
Apoya todas las actividades de GxP en el departamento de Calidad. Administra Sistemas/Procesos de Calidad incluyendo documentación, métricas y seguimiento de acciones. Apoya el establecimiento de procesos operativos de Calidad. Realiza actividades rutinarias de cumplimiento de GxP / operativas de acuerdo con los estándares de calidad de Novartis. Apoya Proyectos e iniciativas de Calidad.
**About the Role**
Este es un reemplazo temporal de licencia de maternidad y ofrecemos un contrato temporal.
**Major Accountabilities:**
- Administra la recepción de materiales crudos y materiales de producción; Asegura el orden correcto y la limpieza de los armarios y refrigeradores para el almacenamiento de reactivos, estándares, materiales crudos y materiales de producción;
- Apoya al jefe de CQ en la ejecución de las diversas actividades bajo la responsabilidad del Departamento de Control de Calidad (preparación de estándares y reactivos, monitoreo microbiológico de instalaciones farmacéuticas, gestión de Counter-sample y envío de muestras a empresas externas para controles de calidad complementarios, calibración periódica y calibración de instrumentos analíticos);
- De la coordinación de la respuesta QC, realiza las actividades necesarias para la correcta ejecución de las diversas actividades del laboratorio de Control de Calidad;
- Asiste a las personas encargadas de la radioprotección en la gestión de instrumentos de medición de radioactividad (probes de monitoreo ambiental, contaminantes, medidores de Geyger-Muller, dosímetros activos y pasivos) y en el manejo de tanques de descontaminación;
- Realiza los controles de calidad de los diferentes radiofármacos;
- Gestiona técnicas analíticas como: cromatografía líquida de alta resolución, cromatografía en gas, TLC, ph-metro, medidor de actividad, método de detección de endotoxinas, etc;
- Cumple con los estándares de manufactura correctos aplicados a la calidad de los radiofármacos.
**Responsabilidades adicionales:**
- Colabora en la implementación y revalidación de procesos de control de calidad;
- Requiere título de grado;
- Afinitad fuerte con y conciencia de problemas de calidad;
- Colaboración y comunicación abierta y clara para asegurar que la operación diaria se realice de manera fluida;
- Capacidad para trabajar bajo presión y comprensión del sentido de urgencia alrededor de las tareas asignadas;
- Fluente en español, conocimiento medio-bueno de inglés es preferido;
- Formación en seguridad radiológica es deseable.
**Ofrecemos:**
Un salario base competitivo en el mercado en consonancia con su cualificación, experiencia y habilidades individuales, opciones de aprendizaje y desarrollo y oportunidades de carrera a nivel mundial dentro de una empresa multinacional de medicamentos en crecimiento que desarrolla un trabajo con impacto directo en pacientes con cáncer.
**¿Por qué Advanced Accelerator Applications?**
Miles de personas mueren de cáncer en todo el mundo cada día. En Advanced Accelerator Applications, una empresa de Novartis, nuestra misión es transformar vidas a través de la terapia de radioligando en medicina nuclear para combatir varios tipos de cáncer.
