R&D Analytical Development Scientist I

hace 1 mes

León, España Pci Pharma Services A tiempo completo

Funciones: El Técnico Jr de Desarrollo Analítico, bajo la dirección del Supervisor del Departamento y reportando al mismo, con el soporte del Técnico Sr, es la persona que lidera los proyectos del departamento a través de la investigación bibliográfica y evaluación de los métodos analíticos a transferir desde los laboratorios del cliente, optimización y/o desarrollo (tanto para proyectos propios o de cliente). Así mismo, es el encargado de preparar los protocolos de Transferencia o Validación de los métodos analíticos y de los informes asociados a ellos, todo ello con la normativa aplicable en vigor (GMP, FDA, etc.) y a los procedimientos internos de la compañía.
Elaboración de protocolos de transferencia y validación de métodos analíticos así como de los informes correspondientes.Desarrollo y/o optimización de métodos analíticos nuevos o ya existentes.Gestión, organización y supervisión de los Analistas de Desarrollo Analítico asignados para la ejecución de las actividades experimentales, así como soporte a nivel técnico de los mismos y del personal en formación.Revisión de la documentación generada por los Analistas de Desarrollo Analítico y evaluación de datos, estudio de tendencias.Comunicación con el cliente.Verificación de nuevas monografías USP, EP.Participación y soporte en los eventos de calidad (OOS, OOT, Desviación, Controles de Cambios, CAPA's, incidencias, reclamaciones y otros eventos de calidad que apliquen), así como elaboración y/o revisión de Especificaciones, Procedimiento de Análisis, requerimientos especiales y otros procedimientos de Laboratorio o relativos.Soporte analítico para la preparación de la documentación técnica del producto: TIP, DMF, CTD, DL.Colaboración con el departamento de Control de Calidad en la evaluación para la adquisición de nuevos equipos, así como en las propuestas de calibración, verificación y mantenimiento de los mismos.Colaboración con el departamento de Control de Calidad en la gestión, organización y limpieza del laboratorio.Participación en auditorías internas y externas (de clientes o autoridades sanitarias competentes).Desempeñar sus funciones siguiendo los criterios de calidad, las normas de seguridad e higiene establecidos por la compañía.No es necesaria experiencia.
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