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QUALIFIED PERSON (QP)

Descripción de la oferta de empleo

Solutia Life Siciences (división de recruitment de Solutia) especializados en perfiles técnicos y de middle management en sectores farmacéutico, biotech y medical devices.Actualmente seleccionamos un/a QP para una Empresa de servicios científico-técnicos dirigida a empresas del sector químico-farmacéutico y veterinario, ubicada en Cerdanyola del Vallés.Funciones:• Revisar y aprobar la documentación involucrada en la actividad analítica de la empresa: CoA, Site Master File, SOPs, especificaciones de producto.• Participar e involucrarse en la revisión de los registros de lotes de fabricación y empaques y otros documentos de revisión de lotes de productos que se lanzarán.• Participar en la certificación de lotes susceptibles de ser liberados al mercado (QP release) y asegurar la aplicación de las GMP de acuerdo a la autorización de comercialización del producto farmacéutico terminado.• Participar en la certificación de lotes de medicamentos en investigación susceptibles de ser liberados para un ensayo clínico y asegurar la aplicación de las GMP de acuerdo con el Expediente de medicamentos en investigación.• Participar en la evaluación de desviaciones, OOS/OOT, quejas, CAPA y Controles de Cambios.• Revisión de la revisión de los Acuerdos Técnicos/de Calidad entre la empresa y los subcontratistas, especialmente en lo que respecta a las actividades de certificación de lotes.• Colaborar en auditorías realizadas por nuestros clientes o fabricantes subcontratados y dar soporte en las Inspecciones de las autoridades reguladoras.• Participar en la implantación y mejora de la calidad de la empresa y de los subcontratistas.Se requiere:• Licenciado/a en Farmacia• Experiencia en Aseguramiento de la Calidad o Control de Calidad o Fabricación en la Industria Farmacéutica.• Valorable experiencia en productos biológicos.• Nivel alto de Inglés.Se ofrece:• Contrato indefinido.• Salario según experiencia aportada
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Detalles de la oferta

Empresa
  • Solutia
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 25/12/2024
Fecha de expiración
  • 25/03/2025
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