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Quality Control Quality Assurance Officer

hace 3 meses

Sant Cugat, Barcelona, España Ferrer A tiempo completo

Responsibilidades

Participar en la implementación del Plan Estratégico de Calidad Corporativa en su ámbito de aplicación. Asegurar el cumplimiento de las normas internas de Ferrer, los estándares de referencia del Sistema de Calidad Farmacéutico en su ámbito de actuación, incorporando iniciativas para la mejora continua. Participar en la monitorización de "Key Quality Indicators" (KQIs) que permitan medir el buen funcionamiento del Sistema de Calidad. Redactar y revisar Procedimientos Normalizados de Trabajo (PNTs) y otros documentos controlados, para el desempeño de funciones dentro del departamento de Calidad y áreas operacionales en ámbito de aplicación y garantizar el estado actualizado y vigente de la misma. Mantener de forma adecuada el archivo de documentación GxP-relevante en su ámbito de aplicación. Participar en la implementación, gestión y mantenimiento del sistema de gestión de desviaciones y Acciones Correctivas y Preventivas (CAPAs). Participar en la gestión de Control de Cambios garantizando la trazabilidad y correcta implementación de dichos cambios en cumplimiento con las prácticas de data integrity. Actuar como enlace entre/con las unidades funcionales y colaboradores para promover la estandarización, mejorar la comunicación, y potenciar la eficiencia de los sistemas de calidad mediante la cooperación en línea con la estrategia del departamento. Participar en la toma de decisiones que se realiza en base a criterios científicos apoyados en herramientas de Gestión de riesgos, según la conveniencia. Participar en auditorías internas, externas e inspecciones Asegurar y ejecutar, según aplique, la formación inicial y continuada GxP relacionada con las áreas asignadas. Contribuir en proyectos estratégicos transversales de Compañía y/o de Desarrollo asegurando cumplimiento con la Normativa GxP aplicable. Revisión de toda la documentación analítica (datos primarios y metadatos) relacionada con los lotes de productos intermedios, semielaborados y acabados (incluyendo resultados de estabilidad) con el fin de verificar el cumplimiento GxP y asegurar la integridad de los datos. Gestión, soporte técnico y evaluación de las desviaciones y de los incidentes originados en control de calidad, incluidas las investigaciones de resultados OOS, OOE, OOT y OOL. Revisión y/o aprobación de especificaciones LIMS Revisión y/o aprobación de la documentación relacionada con cualificaciones equipos, instalaciones y servicios, así como de procesos específicos del área de Control de calidad. Gestionar las reclamaciones recibidas de clientes de productos fabricados por Ferrer originadas en el área de Control de Calidad.

¿Por qué Ferrer?

Impactar positivamente en la sociedad Posibilidad de participar en acciones de voluntariado. Cultura corporativa basada en la confianza y la responsabilidad. Modelo de trabajo hibrido y colaborativo. Oportunidades de Desarrollo y aprendizaje continuo. Tickets restaurant en caso de jornada partida. Retribución flexible Plan apoyo a las personas (asesoramiento psicológico, legal y financiero).

Requisitos

Lo que necesitarás para tener éxito

Si eres una persona empática, humilde, inquieta y optimista, Ferrer es tu empresa

Serás el mejor en este papel si coincides con:

Graduada/o en ciencias químicas, ciencias de la salud o equivalente. Experiencia mínima de 2 años (idealmente 5 años) en un puesto similar en garantía de calidad o en posiciones técnicas de responsabilidad en un laboratorio de control de calidad, bajo normativa GMP. Persona experimentada en control de calidad que esté preparada para evolucionar a una posición más global de vigilancia de la calidad (Quality Oversight), dentro de un departamento de control de calidad.

Si crees que tu perfil puede encajar y tienes ganas de iniciar un nuevo proyecto apasionante, te estamos esperando

En Ferrer garantizamos la igualdad de trato y oportunidades en la contratación, evitando prejuicios y estereotipos por cualquier motivo en los procesos de acceso a la empresa, valorando únicamente criterios objetivos como las competencias profesionales, académicas y la experiencia laboral.