Quality Engineer Iii
hace 1 semana
**OBJETIVO DE LA POSICION**:
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.
**RESPONSABILIDADES CLAVE: DESCRIBA EL ALCANCE**:
**% DEL TIEMPO O**:
**IMPORTANCIA**:
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.
**10%**
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.
**25%**
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.
**15%**
Identificar y realizar mejoras en los procedimientos del área de Microbiología, por ejemplo mediante la ejecución de _gap analysis _de estándares o regulación aplicable.
**5%**
Revisión y aprobación de “_Further investigations_” relacionadas con quejas asignadas al área de Microbiología.
**15%**
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.
**15%**
Asegurar la disponibilidad de indicadores biológicos (y suministros relacionados) y evaluar su uso adecuado en validaciones de proceso u otras actividades donde se requieran.
**5%**
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.
**10%**
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.
**Diario**
Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.
**Diario
Todas las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato.
**Diario**
**CALIFICACIONES DEL PUESTO (REQUERIMIENTOS MINIMOS)**:
**Educación y Experiência**
- Bachiller en Microbiología o Biotecnología
- 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.
**Otras habilidades profesionales**:
**Conocimiento Técnico**:
Requerido conocimiento en sistemas de Gestión de Calidad (GMP, QSR, FDA, ISO, CAPA)
Requerido conocimiento en herramientas para la solución de problemas
Bilingüe español-inglés / Intermedio - avanzado
Dominio de programas en ambiente Windows
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