QA Specialist FA / Hold
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.
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Support for Parents
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Continuing Education/ Professional Development
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Employee Heath & Well-Being Benefits
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Paid Time Off
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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
QA Specialist FA / Hold
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B 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 separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Garantizar la calidad de los productos en toda la cadena de suministro, incluyendo las regulaciones vigentes y corporativas aplicables a todos. centros de almacenamiento de producto terminado, asegurando Buenas Prácticas • Soporte a procesos de SGC para LATAM.
Específicamente Administrar proceso de Acciones en Campo / Retenciones Locales y Corporativas para todos los países de LATAM.
Dar soporte Regulatorio para los países de LATAM: Armado de Dossier, seguimiento y gestion de tramites. Apoyo en la documentación de CC de la función de RA.
Lo que realizaras en Baxter:
Seguimiento a la ejecución de los procesos de Acciones de Campo y Retenciones Corporativas para asegurar el mantenimiento dentro de las metas globales de los indicadores de FA's y hold para los países de los Clusters Mexico y Colombia excepto Mexico, y Brasil.
Responsable de mantener actualizados los procedimientos que gobiernan los procesos de Acciones de Campo y Retenciones Corporativas de acuerdo a las necesidades de cada país, cambios de GQP's y cambios a las regulaciones aplicables que impacten dichos procesos.
Relacionamiento con clientes internos de las diferentes funciones que participan en el proceso de ejecución de FA y con clientes externos para dar soporte con la ejecución de las acciones decampo
Administrar los KPIs de los procesos de FA´s y hold corporativo, local y entrenamiento.
Evaluar las acciones de campo (FA´s) y determinar reportabilidad a los Ministerios locales ya sea en el programa de Tecnovigilancia o Farmacovigilancia
Ejecutar los reportes a los programas de Tecnovigilancia o Farmacovigilancia cuando sea aplicable en los países impactados
Identificar riesgos de cumplimiento y legales de Baxter en el país/cluster.
Liderar el proceso de acciones de campo corporativos y locales para los países de los Clusters Mexico y Clúster Sur incluido Colombia excepto (Mexico y Brasil)
SME para el proceso de hold y FAS
SME en JDE para los módulos de QA
SME para los software de FA's y Hold
Lo que aportaras en Baxter:
5 a 8 años de experiencia en Aseguramiento y Sistema de Calidad
Manejo de paquetería Windows (Word, Excel, Power Point, paquete office, SharePoint, Webex, Teams-)
Manejo de JDE.
Inglés fluido.
Experiencia en manejo de proyectos
Conocimiento en BPM, BPD, y en regulaciones de Tecnovigilancia y Farmacovigilancia
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.
Address
Cali Valle del Cauca
Colombia Explore This Location
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Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.