Quality Engineer Iii
hace 6 meses
**Company Description**
Asegurar el cumplimiento de las regulaciones relacionadas al control microbiológico propias de la industria y el cumplimiento de procedimientos oficiales en los proyectos en que participe y en las tareas propias de su cargo.
- Identificar controles microbiológicos adecuados y asegurar que estos sean implementados en los proyectos donde se requiera, por ejemplo: mejora de productos / procesos y proyectos desarrollo / introducción de nuevos productos.
- Diseñar protocolos de validación relacionados con métodos del Laboratorio de Microbiología o con sistemas críticos (HVAC, RODI, aire comprimido) y gestionar los recursos para permitir la ejecución adecuada y oportuna.
- Realizar las revisiones periódicas requeridas por los procedimientos del área de Microbiología (por ejemplo: revisiones anuales (cumplimiento clase ISO, bioburden, esterilización, endotoxina, etc.) y recálculo de límites de alerta / acción de pruebas ambientales). Asegurar la ejecución de cambios en procedimientos como resultado de dichas revisiones o recalculos.
- Identificar y realizar mejoras en los procedimientos del área de Microbiología, por ejemplo mediante la ejecución de gap analysis de estándares o regulación aplicable.
- Revisión y aprobación de “Further investigations” relacionadas con quejas asignadas al área de Microbiologí
- Asegurar la correcta (re)calificación de equipos y proveer soporte técnico para la ejecución de validaciones de ciclos de esterilización y calificación de esterilizadores, por medio de la revisión de protocolos y reportes.
- Asegurar la disponibilidad de indicadores biológicos (y suministros relacionados) y evaluar su uso adecuado en validaciones de proceso u otras actividades donde se requieran.
- Realizar investigaciones de causa raíz para eventos relacionados con validaciones de Microbiología (incluyendo ciclos de esterilización) o Sistemas Críticos e implementar acciones para su solución.
- Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos. Así mismo, garantizar el cumplimiento mediante la adopción de estrategias, controles internos comunicación y entrenamientos necesarios.
- Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.
- Todas las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato.
**Qualifications**
- Bachiller en Microbiología o Biotecnología
- Inglés intermedio
Deseables:
- Experiência de al menos dos años como microbiólogo o biotecnólogo en industria médica.
- Habilidades para redacción clara de documentos regulatorios y reportes.
- Experiência en administración de proyectos.
**Additional Information
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