Químico De Documentación Técnica Y Proyectos

Company: LupinLocation: CMX, MXJob DescriptionGestionar, revisar, y proteger la documentación generada en Investigación y Desarrollo para la integración de expedientes técnicos para medicamentos y dispositivos médicos (nuevos registros y modificaciones).
Ensure compliance with national and international standards, pharmacopoeias, and guidelines, coordinating with internal and external multidisciplinary areas during development.Manage and validate the translation of required technical documentation, ensuring its integrity compared to the original documents.Prepare technical justifications and respond to requests from health authorities regarding technical dossiers.Verify calculations in formulation documentation, analytical development, validation, and stability studies.Assign codes and manage documentation and procedures related to technical dossiers and project administration.Define, plan, and monitor project activities, timelines, milestones, and responsible parties using sche...