QA Release Officer
hace 3 semanas
El QA Release Officer garantiza que los medicamentos comerciales puestos en el mercado cumplen con los requisitos de fabricación, análisis y distribución según la legislación vigente y procedimientos internos, así como según las condiciones establecidas en la Autorización de comercialización del medicamento emitida por las Autoridades Sanitarias. Responsable de la revisión de las muestras y documentación relacionada. Responsable de la liberación para la distribución (Release for Distribution).
**Tus responsabilidades sin límites**:
- Realización de la revisión de la documentación de lote previa a la liberación por parte del QP.
- Iniciación y obtención del EU Batch Certificate de los productos centralizados. Evaluación del transporte de medicación comercial y valoración en caso de excursiones de temperatura.
- Gestión y priorización de las urgencias y liberaciones.
- Gestión del reacondicionamiento de lotes comerciales conforme a GMPs.
- Asegurar la implementación de SLC conjuntamente con Supply, DRA y otros departamentos relacionados.
- Reporte y seguimiento de los indicadores mensuales.
- Gestión docuteca y muestroteca.
- Colabora con el QP en temas necesarios.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**Requisitos obligatorios**:
- Licenciatura en Ciencias de la Salud
- 3 años de experiência en Garantía de Calidad y/o Control de Calidad.
- Alto conocimiento de las GMPs y procesos de fabricación de medicamentos.
- Español nativo y Inglés nível alto
**¿Qué te ofrecemos?**
- Salario competitivo (salario fijo + bonus anual)
- Un amplio abanico de beneficios sociales: plan de pensiones, seguro médico gratuito, cantina con menú parcialmente subvencionado, seguro de vida y accidentes, descuentos en plataformas de gimnasio y salud, plataforma virtual de descuentos, ayudas económicas, permisos ampliados, y mucho más
- Un entorno dinámico en el que aprender y desarrollarte:
- Cursos de inglés y plataforma con un catálogo extenso de formaciones internas.
- Programas de formación y desarrollo en liderazgo para Managers
**Division**
Operations
**Business Unit**
QUALITY
**Country**
Spain
**Work Location**
Barcelona Gran Vía
**Company/Legal Entity**
Novartis Farmacéutica, S.A.
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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