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Debe asegurar: Que se cumplan los principios de Quality by Design Que se transfiera un producto robusto, con un proceso bien comprendido En la validaci\u00f3n de procesos: Coordinar actividades relacionadas a validaciones de procesos en la planta de manera de asegurar la programaci\u00f3n de los ejercicios de validaci\u00f3n de procesos y el cumplimiento del programa de validaci\u00f3n. Emitir protocolos e informes de validaci\u00f3n de procesos y participar en las actividades de validaci\u00f3n correspondientes, gestionando lo necesario con las \u00e1reas de producci\u00f3n involucradas. 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