Quality Assurance

hace 6 días

Santiago, Metropolitana, Chile F. Hoffmann-La Roche Gruppe A tiempo completo

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position Sistema de Calidad y operaciones de calidad
  • Asegurar el cumplimiento local de las directrices de Roche y las regulaciones vigentes en relación a la calidad de los productos que Roche comercializa en el mercado local.
  • Liberación: Realizar liberaciones de productos en el sistema SAP una vez que se cuente con la aprobación del Director Técnico así como documentar adecuadamente el proceso de liberación.
  • Manejo de reclamos: Recepcionar consultas y reclamos de clientes, reportar y dar seguimiento de investigaciones con los sitios de manufactura e ISP, según corresponda.
  • Destrucción: Coordinar la destrucción de productos vencidos y en mal estado como back up del Director Técnico.
  • Análisis local: Solicitar y mantener disponibilidad de estándares de referencia para continuidad de análisis locales.
  • Control de productos biológicos: Solicitar Control de Serie, adelantos de control de serie o exclusión de control de serie para productos biológicos y/o Exención de Control de Calidad, según corresponda.
  • Controles de cambio: Gestionar control de cambio y coordinar con el área regulatoria la ejecución del plan de acción (si procede) hasta el cierre del proceso.
  • Transferencias analíticas: Coordinar las labores de transferencias de métodos analíticos entre laboratorios externos de control de calidad y los sitios de manufactura.
  • Desarrollo de programas de capacitación y entrenamientos relacionados a la operación logística y buenas prácticas
  • Gestión y archivo de documentación regulatoria y de calidad de acuerdo a buenas prácticas de documentación
  • Auditorías: Preparar, coordinar y realizar, en conjunto con el Director Técnico, auditorias de calidad a proveedores
  • Colaboración con la Network de Calidad Roche en operaciones e iniciativas compartidas.
Supervisión y manejo de proveedores
  • Gestionar las relaciones con proveedores externos, como logísticos o laboratorios de análisis, incluidos acuerdos de calidad, seguimiento de métricas de desempeño y actividades de control de calidad.
  • Implementar medidas de control de calidad, incluida la calificación de proveedores, auditorías de proveedores y procedimientos de prueba de productos.
  • Realizar revisiones y evaluaciones periódicas de los sistemas, procesos y documentación de calidad para identificar áreas de mejora e implementar acciones correctivas.
  • Coordinar con los proveedores de laboratorios de control de calidad para garantizar pruebas precisas y oportunas de productos, materias primas y productos terminados.
  • Realizar seguimiento continuo respecto de los planes de manejos de riesgo tanto de la unidad de calidad de Roche como de los proveedores logísticos y laboratorios de análisis externos..
  • Gestión y monitoreo desviaciones del sistema de calidad y de terceros contratados como operador logístico y laboratorios de análisis, incluyendo seguimiento de las CAPAs
  • Manejo y monitoreo de proceso de devoluciones con el operador logístico
  • Coordinar labores de reacondicionamiento con el operador logístico, cuando sea requerido.
  • Asegurar inventarios cíclicos en la droguería
Conocimientos
  • Se prefiere una licenciatura en Química y Farmacia, Ingeniero
    Químico, Bioquímica, Química, o su equivalente en Ciencias
    Farmacéuticas
  • Experiencia laboral 2 años al menos en áreas de
    Aseguramiento de Calidad (QA), Control de Calidad (QC) o
    análisis de calidad en entornos de laboratorio.
  • Manejo intermedio del idioma inglés.
  • Conocimiento sistema SAP, Veeva y Trackwise (deseable)
  • Conocimiento de regulación local asociada a análisis, almacenamiento, distribución de productos farmacéuticos y guías internacionales de buenas prácticas: Manufactura (GMP), Distribución GDP, de Laboratorio (GLP)
  • Competencias Capacidad para enfocarse en crear valor en
    línea con los objetivos corporativos.
  • Capacidad para movilizar equipos construyendo relaciones
    efectivas.
  • Capacidad de promover el trabajo en equipo, la
    colaboración y compartir información.
  • Capacidad de promover una comunicación abierta y
    bidireccional.
  • Capacidad para establecer objetivos y obtener resultados.
  • Capacidad para asegurar que los procesos y sistemas
    funcionen correctamente.
  • Capacidad de innovación, aprendizaje y adaptación al
    cambio.
  • Capacidad de fomentar y valorar la diversidad, aplicar
    nuevos conocimientos.
  • Integridad (ética, honestidad y probidad).
  • Coraje (experimenta, toma riesgos necesarios y
    adecuados).
  • Pasión (energiza, compromete e inspira a otros).
Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

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