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Quality Assurance Release Officer

hace 3 meses

Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

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:

  • Gestión aspectos de Calidad y proyectos dentro del área de responsabilidad.
  • Garantizar y respaldar la conformidad general de GxP y el cumplimiento de los sistemas de gestión de calidad de Novartis
  • 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.

Requisitos obligatorios:

  • Licenciatura en Ciencias de la Salud 3 años de experiencia en Garantía de Calidad y/o Control de Calidad.
  • Alto conocimiento de las GMPs y procesos de fabricación de medicamentos.
  • Español nativo y Inglés nivel 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 ManagersKey Performance IndicatorsBarcelona Gran Vía#J-18808-Ljbffr