Especialista en Calificación y Validación
Toluca, Mexico Permanent Posted on Nov. 28, 2024 Closing on Dec. 20, 2024Cargo: Especialista en Calificación y Validación
- Ocoyoacac
- 100% presencial
- Tipo de contrato: Indeterminado
Acerca de la posición
Nuestro equipo:
Como Especialista en Calificación y Validación, serás responsable de asegurar que los programas de calificación y revisión periódica se cumplan con apego a políticas de la compañía, estándares nacionales e internacionales, así como del seguimiento a las acciones asignadas del Sistema de Gestión de Calidad. Dará seguimiento puntual a la resolución oportuna de la calificación de equipos, sistemas críticos y no críticos, instrumentos de proyectos del sitio.
Descripción Específica: (Principales Responsabilidades)
- Dar cumplimiento a las actividades asignadas del Plan Maestro de Validación del Sitio, con excepción de Laboratorio, con respecto a calificación y revisión periódica de equipos, sistemas críticos y no críticos, instrumentos y áreas siguiendo el ciclo de vida de calificación y validación, generando la estrategia de cada sistema de acuerdo con el Plan Maestro de Validación del sitio y dando seguimiento a la programación oportuna con los usuarios para el préstamo de los sistemas y equipos y la ejecución de estos.
- Generar protocolos y reportes de calificación y revisión periódica de equipos, sistemas e instrumentos y participar en la generación revisión y/o aprobación según aplique de toda la documentación asociada (análisis de riesgos, evaluación y clasificación de riesgos GxP, de equipos, sistemas y componentes, inventarios de equipos y sistemas, URS, no conformidades, etc).
- Generar los PNO's que sean requeridos por cumplimiento de GMP’s dando seguimiento a la actualización en tiempo de los PNOs y generando análisis de impacto y calidad cuando se aplica.
- Dar seguimiento a la generación y cierre en tiempo de Desviaciones, CCR, Análisis de riesgos y al cierre oportuno de los hallazgos de calidad, derivados de ejecuciones o auditorias e inspecciones.
- Cumplir con los requisitos de HSE y con las GMP's.
- Conocer y capacitarse en los cursos relacionados a HSE y GMPs, dar seguimiento a los proveedores de los servicios de calificación asegurando que cumplan con los requerimientos de seguridad y de GMP´s y participar cuando sea requerido en las diferentes auditorías de Calidad y HSE.
Acerca de tí
- Experiencia: Contar experiencia amplia en posiciones similares en la industria farmacéutica.
- Habilidades sociales: Capacidad de análisis y solución de problemas complejos, orientado a resultados.
- Habilidades técnicas: Conocimientos en normatividad aplicable a la industria farmacéutica (NOM-059) y conocimiento avanzado en validación y calificación.
- Educación: Ingeniero mecatrónico, Ingeniero eléctrico, Ingeniero mecánico, Ingeniero Farmacéutico, Químico Farmacéutico Industrial, Químico Farmacéutico Biólogo, Ingeniería Química u otra carrera afín
- Idiomas: Inglés Intermedio
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