Analyst File Documentation Control

hace 6 días


Tijuana, México BAXTER A tiempo completo

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Objetivo principal del puesto**:
Dar soporte y ejecutar actividades establecidas al Departamento de Documentación, funge como responsable de mantener actualizado, en análisis y en cumplimiento el proceso de resguardo de documentos generados en la operación de la planta.

**Principales Actividades y Responsabilidades**:

- Vigilar el cumplimiento de los requisitos de la regulación FDA de países a donde se exporta el producto, estándares internaciones ISO 13485 y requisitos corporativos, así como también, dar cumplimiento al proceso de la administración del riesgo cuando aplique.
- Brindar atención significativa e involucramiento directo en Auditorías internas y externas del SGC.
- Brinda soporte en el cumplimiento del Sistema de Calidad mediante su participación en investigaciones asegurando que las actividades relacionadas al seguimiento de un NCR/CAPA asociados al área de Documentación para la correcta ejecución y cierre en tiempo y forma.
- Asegura la custodia de manera ordenada y clasificada para el fácil acceso de búsqueda y consulta tanto de los documentos físicos como en el sistema electrónico para cada área.
- Digitalizar, controlar, mantener y resguardar el archivo electrónico y físico de la información (DHRs, protocolos de validaciones y documentos regulatorios que apliquen) para el Sistema de Gestión de Calidad.
- Responsable de asignar y asegurar los periodos de retención correctos para los documentos dentro del archivo físico, de acuerdo a las políticas y procedimientos relacionados.
- Dar orden al archivo físico y electrónico de documentos, asegurando el correcto almacenamiento y destrucción de los mismos.
- Programar reuniones para la entrega de documentos de los diferentes departamentos, retención, registros y control de cambios, así como obsoletos.
- Gestiona reuniones con los delegados por área para la destrucción de documentos que cumplen con su periodo de retención.
- Es responsable de mantener actualizado, administrar y auditar el archivo sistematizado (electrónico) con la información de la documentación que entra al área de resguardo, para demostrar el grado de cumplimiento y conformidad con el Sistema de Gestión de la Calidad.
- Apoya el cumplimiento del Sistema de Calidad mediante su participación para realizar actividades adicionales y requeridas por el jefe inmediato.
- Cumplir con los sistemas de Seguridad e Higiene, ISO 14001 (Gestión Ambiental) y de acuerdo a la NOM-041, así como los que apliquen.
- Aplicar y seguir los lineamientos de EHS de acuerdo con los procedimientos, estándares y normas oficiales mexicanas aplicables. Usar el equipo de protección personal (EPP) asignado de acuerdo con la NOM-017.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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