Eng, Validation

hace 5 meses

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.

1. Vigilar el cumplimiento de los requisitos de la regulación FDA de países a donde se exporta el producto, estándares internacionales (ISO 9001/ISO 13485) y requisitos corporativos con especial atención al 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198.
2. Análisis estadístico de la variación de los procesos, control de procesos/productos, análisis de riesgo de las familias de producto de la planta, implementación de acciones de mejora resultante del análisis de datos de la experiência del producto interna y externa.
3. Asegurar el cumplimiento a la normatividad aplicable para mantener el estatus de validación.
4. Realizar las actividades del proceso de calificación y validación.
5. Calificar equipos y sistemas críticos usados en la manufactura de procesos.
6. Dar cumplimiento al Plan Maestro de Validación vigente.
7. Revisar protocolos y reportes de validación.
8. Recopilar información anexa a los protocolos de validación.
9. Elaborar y mantener actualizados los procedimientos aplicables a los procesos de calificación y validación de acuerdo con los estándares corporativos y la legislación nacional e internacional.
10. Dar cumplimiento a GAMP 5, Annex 11 EC, CFR 21 parte 11 y estándares internacionales enfocados a la validación de sistemas computacionales y aplicación de integridad de datos
11. Asegurar la calificación y operación de las áreas controladas dentro de las especificaciones ambientales aplicables.
12. Formar parte de la estructura en la toma de decisiones concernientes al cumplimiento regulatorio y de estándares de calidad en todas las operaciones antes descritas.
13. Apoyo directo en las inspecciones regulatorias.
14. Cumplir con los sistemas de Seguridad e Higiene, ISO 14001 (Gestión Ambiental) y de acuerdo con la NOM-041, así como los que apliquen.
15. Aplicar y seguir los lineamientos de EHS de acuerdo con los procedimientos establecidos, estándares y normas oficiales mexicanas.
16. Usar el equipo de protección personal (EPP) asignado de acuerdo con la NOM-017.
17. Apoya el cumplimiento del Sistema de Calidad mediante su participación en investigaciones como dueño asegurando que las actividades relacionadas al seguimiento de un NCR/CAPA son ejecutadas, completadas y documentadas correctamente.
18. Además de en caso de tener participación como aprobador de calidad tiene la responsabilidad de asegurar que las investigaciones hayan tenido una adecuada investigación de causa y que los cierres de investigación o acciones hayan sido ejecutados correctamente, cumplan los requerimientos del sistema y sean documentados apropiadamente.

19. Responsable de la elaboración, coordinación y ejecución de protocolos de validación y calificación para dar cumplimiento a las políticas internas de Baxter y a las normas internacionales, así como también fortalecer el mejoramiento continuo en los procesos de manufactura y producción de servicios críticos de planta.

**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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