Químico de Documentación Técnica y Proyectos

Company: Lupin

Location: CMX, MX

Job Description

• Gestionar, 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.
• Defi...