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Compliance Analyst

Req # JR - 144648 Location Jiutepec, Morelos, México Job Category Quality Date posted 12/11/2024
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Compliance Analyst

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Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Tu rol en Vantive:

Salvar y sostener vidas siendo el responsable de apoyar al cumplimiento de las condiciones de registro de productos comercializados y proveer al área de Asuntos Regulatorios la documentación requerida para el dossier de producto para realizar trámites de altas, bajas y modificaciones de registros ante Ministerios de Salud tanto para productos nacionales, importados y para exportación.

Tu equipo:

Desarrollamos productos de calidad pensando en el paciente, por lo que nuestros esfuerzos también se centran en el paciente. Eso significa que puedes estar orgulloso de nuestro trabajo y del valor que brindamos a las personas todos los días.

Como parte de una gran organización multinacional, tienes la oportunidad de ampliar tu conocimiento a través de la colaboración con una variedad de personas, la exposición a diferentes facetas de nuestro portafolio y un equipo de liderazgo de apoyo que fomenta el desarrollo continuo.

Lo que realizarás en Baxter :

1. Apoyar al cumplimiento de las condiciones de registro de productos comercializados y proveer al área de Asuntos Regulatorios la documentación requerida para el dossier de producto.

2. Apoyar al cumplimiento de las condiciones de registro de productos comercializados.

3. Proveer al área de Asuntos Regulatorios la documentación requerida para el dossier de producto para realizar trámites de altas, bajas y modificaciones de registros ante Ministerios de Salud tanto para productos nacionales, importados y para exportación.

4. Dar soporte a los procesos y/o documentación de maquila aplicables.

5. Dar cumplimiento a los requisitos regulatorios para la liberación de productos importados comercializados en México y liberados en Civac.

6. Garantizar el cumplimiento de las políticas, procedimientos, normatividad local y corporativa.

7. Realizar la documentación de soporte necesaria aplicando las Buenas prácticas de Documentación.

8. Tener como prioridad su seguridad y la calidad del producto.

9. Realizar cambios y/o actualizaciones a PNO’s de acuerdo a regulaciones vigentes.

10. Fomentar una cultura de cumplimiento de normas y prácticas de negocio éticas en la organización.

11. 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.

12. Asegurar y mantener la calidad del producto mediante el cumplimiento del sistema de calidad.

13. Conjuntar la información para solicitar a COFEPRIS automuestreo y liberación, desenfajillado y muestreo de los productos hemoderivados. 

14. Solicitud y administración de estándares y reactivos de los productos importados.

15. Solicitar Permisos de importación de Medicamentos, Dispositivos y Reactivos.

16. Coordinar el muestreo de productos importados y gestionar resultados con laboratorios terceros.

17. Realizar protocolos de calificación/recalificación de cámaras climáticas.

18. Dar cumplimiento al Plan Maestro de Productos Importados

Lo que aportarás:

1. Profesional universitario titulado en Licenciatura en Farmacia, Ingeniero Bioquimico, Ingeniero Biotecnólogo o afines.

2. Ingles Intermedio- Avanzado

3. Experiencia mínimo de 1año en generación de permisos de importación, cronogramas, calificación de cámara climática, calificación a los equipos, validación de equipos, renovación de registros sanitarios, coordinar requisitos regulatorios para sometimiento de registro sanitario, administra cumplimiento regulatorio de leyendas.

#LI-BAXGEN

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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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Address

Explore this location Av de los 50 metros # 2 Civac Jiutepec
Ecatepec
62500 Jiutepec, MOR
Mexico
Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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