Quality Assurance Manager

hace 3 semanas


Madrid, España Page Personnel España A tiempo completo

Como responsable de Calidad te encargarás de todas las funciones y requisitos relacionados con la calidad para España:

- Actuarás como contacto principal en España para temas de control de calidad relacionados con distribuidores y organismos externos y autoridades sanitarias.
- Te responsabilizarás de garantizar la calidad e integridad de los medicamentos importados a España, brindando supervisión y apoyo a las actividades relacionadas con GDP.
- Reconocimiento, documentación y reporte de quejas técnicas de productos.
- Coordinarás la capacitación de GMP/GDP en España.
- Realizarás la supervisión y soporte de control de calidad para todas las actividades relacionadas con la Calidad y GMP/GDP.
- Garantizarás el cumplimiento de control de calidad con todas las reglamentaciones nacionales e internacionales, así como los requisitos internos de la Compañóa.
- Te asegurarças de que todos los productos se manipulen de manera adecuada, en particular en lo que respecta a control de las especificaciones del producto, las introducciones de prueba, las condiciones de almacenamiento, las fechas de caducidad y los estándares de calidad.
- Supervisarás, informarás y documentarás las devoluciones de productos.
- Supervisarás al socio logístico.
- Tendrás que ser conocedor de GMP/GDP y requisitos normativos cambiantes, y garantizar la idoneidad de las licencias y los modelos de distribución.
- Asegurarás que los proveedores y clientes estén aprobados, así como cualquier actividad subcontratada que impacte en GMP/GDP.
- Desarrollarás y mantendrás acuerdos locales de calidad.
- Garantizarás que se cumplan todos los requisitos adicionales de las autoridades.
- Tomarás las decisiones locales idnependiente para la disposición de productos retirados del mercado.
- Apoyar las actividades relacionadas con Trackwise, desviaciones, PE, módulo de auditoría, TPC.
- Serás responsable de la calificación y seguimiento de los proveedores de servicios.
- Supervisarás y aprobarás desviciones locales, CAPAs y controles de cambio.

Importante Compañía Biotecnologíca ubicada en Madrid|Posición Temporal como QA Manager
- Licenciatura en Farmacia.
- Experiência previa en Industria farmacéutica de mínimo 3 años en funciones similares.
- Inglés fluido.
- Conocimiento de la ISO 9001, ISO 14001, GMP/GDP, participación en auditorías e inspecciones.
- Muy valorable experiência previa con Trackwise.

Compañía biotecnológica especializada en neurociencia.
- Contrato temporal de duración estimada 9 meses.
- Salario competitivo.
- Muy buena oportunidad para desarrollo profesional.

Importante Compañía Biotecnologíca ubicada en Madrid busca incorporar a su plantilla con un contrato temporal de duración aproximada de 9 meses un/a QA Manager.

Quality Assurance Manager - TEMPORAL (H/M)


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