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Quality Assurance Technician
hace 3 meses
Importante laboratorio dedicado al desarrollo de procesos y a la fabricación de principios activos farmacéuticos, ubicado cerca de Barcelona, está en búsqueda de un/a Técnico de Garantía de Calidad para el departamento de QA.
Las funciones a desarrollar serán las siguientes:
- Revisar y aprobar la documentación de Producción y/o Control de Calidad para realizar la liberación de lotes FDF.
- Garantizar la calidad mediante la aprobación de los protocolos de Validación, Master Batch, Control de cambios y la Liberación de Productos
- Participación en el seguimiento y cualificación de proveedores / CMOS.
- Participación en la revisión y actualización de los sistemas de calidad.
- Preparar y difundir los Product Quality Report, revisión de los sistemas de soporte.
- Coordinar y realizar el seguimiento de los objetivos e indicadores de Calidad.
- Coordinar y preparar las respuestas a reclamaciones y devoluciones.
- Supervisar el seguimiento de los cambios (Change Control).
- Realizar las auditorías internas de la empresa.
- Revisar la gestión de desviaciones, no conformidades, investigaciones relacionadas, acciones correctoras, preventivas y de mejora.
- Coordinar y apoyar en auditorias de entidades certificadoras.
- Redactar, mantener y supervisar los SOPs y Proformas.
Aptitudes y conocimientos deseados:
- Licenciado/a o Grado en Farmacia o similar.
- Experiência en gestión de sistemas de calidad.
- Nível alto de inglés de negocios, oral y escrito. (C1)
- Alta capacidad de trabajo en equipo.
- Disponibilidad para viajar ocasionalmente
- Se valorará Máster en gestión de calidad o relacionado con industria farmacéutica.
Algunos de los beneficios sociales:
- Porcentaje sobre objetivos
- Flexibilidad horaria
- Teletrabajo
- Cheque restaurante
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