- 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.
- Experiencia de al menos dos años como microbiólogo o biotecnólogo en industria médica.
- Habilidades para redacción clara de documentos regulatorios y reportes.
- Experiencia en administración de proyectos.
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Quality Engineer III - Heredia, Costa Rica - AbbVie
hace 1 semana
Descripción
Job DescriptionAsegurar 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.
• Bachiller en Microbiología o Biotecnología
• Inglés intermedio
Deseables:
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
