Quality Engineer Iii

hace 2 semanas


San Francisco, Heredia, Costa Rica ABBVIE A tiempo completo

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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