Quality Control Quality Assurance Officer

hace 2 meses

Sant Cugat del Vallès, España Ferrer Internacional SA A tiempo completo

En Ferrer utilizamos nuestro negocio para luchar por la justicia social. Somos una compañía que lleva años buscando hacer las cosas de manera diferente; en lugar de maximizar el retorno de los accionistas, devolvemos gran parte de nuestros beneficios a la sociedad y los destinamos allí donde verdaderamente hacen falta. Vamos más allá del cumplimiento y nos regimos por los más altos estándares de sostenibilidad, ética e integridad. Por eso, desde 2022 somos una empresa B Corp.

Ferrer se fundó en 1959 y actualmente ofrecemos soluciones transformadoras para hacer frente a patologías graves y debilitantes en más de cien países. En línea con nuestro propósito, tenemos un creciente enfoque en las enfermedades pulmonares vasculares e intersticiales y los trastornos neurológicos. Y a nuestro equipo de 1.800 personas les mueve una clara convicción: el negocio no es un fin en sí mismo, sino un medio para cambiar vidas.

Descripción de la oferta

Tu misión

Como parte del equipo Quality Assurance Pharma Sites, estamos buscando un Quality Control Quality Assurance Officer (QAQC) reportando al Quality Assurance Operations Manager.

  • 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.
  • 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.
  • 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.
Requisitos
  • 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.
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