QA facilities and Equipment

hace 2 semanas


Sin especificar, España Claire Joster A tiempo completo

Desde Claire Joster, estamos buscando un/a Quality Assurance con enfoque a equipamientos e instalaciones para asegurar el cumplimiento del sistema de calidad y GMPs durante el ciclo de vida de la fabricación de los productos en la planta de ESTEVE QUÍMICA ubicada en Celrà (Girona).Tus funciones a desarrollar serán:Soporte en normativas GMPs, GAMP y GDP, referente a equipos, instalaciones relacionadas con Producción (HVAC/Agua/Zonas limpias/Almacenes de temperatura controlada/otros servicios), así como todos los sistemas informáticos (producción, laboratorio).Preparación y aprobación de los análisis de riesgos de calidad.Gestión, revisión y soporte en generación de procedimientos de limpieza y validación de limpieza.Aplicar las herramientas para monitorizar el sistema de calidad.Gestión y Evaluación de las Desviaciones. Participación en las investigaciones de: desviaciones/OOT/OOS/OOE, reclamaciones y devoluciones.Cualificación de los proveedores de materias primeras, material de envasado y de servicios GMP.Aprobación de los maestros de fabricación y de limpiezas, así como de las especificaciones y métodos de análisis.Participación y soporte en auditorías externas (de clientes), de proveedores de materiales y servicios, internas e inspecciones de autoridades. Preparación de las respuestas de las observaciones y documentación relacionada.Preparación y respuesta a los cuestionarios GMPs/GDP que se reciben de los clientes/autoridades y el autocuestionario de la planta.Requisitos:Experiencia enfocada en tareas de QA Sistemas, en concreto, relacionadas con equipos/instalaciones y sistemas informáticos.Licenciatura en Ciencias, preferiblemente Ingeniería técnica, Química o Farmacia.Cursos de Normativa GMP para APIs, en gestión documental y/o PRL y medioambiente.Conocimientos de Office.Catalán y Castellano nativos, Inglés B2.Pensamos en un perfil responsable, proactivo e innovador.



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    Desde Claire Joster, estamos buscando un/a Quality Assurance con enfoque a equipamientos e instalaciones para asegurar el cumplimiento del sistema de calidad y GMPs durante el ciclo de vida de la fabricación de los productos en la planta de ESTEVE QUÍMICA ubicada en Celrà (Girona)Tus funciones a desarrollar serán:Soporte en normativas GMPs, GAMP y GDP,...

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