QA Specialist FA
hace 1 mes
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.
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 de campo.
- 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.
- 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.
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