Specialist in Change Control, Sq and Validations

hace 6 meses

Jiutepec, 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.

**Aquí es Dónde** Salvas y Sostienes Vidas

**Objetivo principal del puesto**:
Dar soporte al proceso de Control de Cambios (CC), Análisis de riesgos (RM), Plan Maestro de Validaciones (o validaciones independientes), así como Calidad de Proveedores para que se ejecuten en cumplimiento con los requisitos del sistema de calidad en los países de Latinoamérica (países del Clúster Colombia y México).

**Actividades**:

- Fomentar una cultura de cumplimiento de normas y prácticas de negocio éticas en la organización.
- Impulsar la implementación del programa de ética y cumplimiento y prevenir, detectar y corregir las violaciones de la ley, las políticas de Baxter y código de conducta.
- Implementar el código de conducta de Baxter, políticas y procedimientos, incluyendo, pero no limitado a la política Global de interacciones y política de terceros y apoyar a los procesos.
- Identificar riesgos de cumplimiento y legales de Baxter en el país/cluster.
- Conocer y seguir las actividades de su puesto de acuerdo con los procedimientos de operación del área.
- Cumplir con las actividades dentro de un marco regulatorio de acuerdo con las buenas prácticas de documentación. Buenas prácticas de fabricación y/o buenas prácticas de almacenamiento.
- Considerar indicadores de desempeño de acuerdo. Con objetivos del área / líder.
- Cumplir con los lineamientos de seguridad e higiene industrial.
- Cumplir con entrenamiento regulatorio o aquel que le permita mejorar sus funciones.
- Cumplir con las expectativas de liderazgo asignadas de acuerdo con la posición.
- Dar soporte a la administración del proceso de control de cambios para el clúster Colombia y México desde su inicio hasta el cierre.
- Administración y seguimiento al proceso de asignación de consecutivo FMEA (análisis de riesgo).
- Administración y seguimiento al proceso de Validaciones (Protocolos de validación desde su apertura hasta el cierre), Plan Maestro de Validaciones y Mantenimiento del Estado Validado.
- Evaluación de Proveedores locales,
- Seguimiento a NSR, SAIs, y aprobación de Reportes de Auditoría en TrackWise 9.

**Escolaridad**:

- Profesional en Química Farmacéutica
- Profesional en Ingeniería Química o afín
- Profesional en Química
- Experiência en manejo de proyectos
- Conocimiento en BPM, BPD, y en regulaciones de Tecnovigilancia y Farmacovigilancia

**Experiência**:

- 5 a 8 años de experiência en Aseguramiento y Sistema de Calidad

**Conocimientos**:

- _ Manejo de paquetería Windows (Word, Excel, Power Point, paquete office, SharePoint, Webex, Teams_-_)_
- _ Manejo de JDE._
- _ Inglés fluido._

**Competencias**:

- Comunicación
- Enfoque al cliente
- Colaboración y Trabajo en equipo
- Pensamiento Crítico y Resolución de problemas
- Manejo de ambigüedad

**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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