Buscamos un(a) Operador(a) de Manufactura de Parenterales para el área de Manatí orientado(a) a resultados, con alto sentido de responsabilidad, ética y trabajo en equipo, que contribuya de manera significativa al cumplimiento de los estándares de seguridad, calidad y productividad en nuestros procesos de manufactura.
Descripción de Puesto: Operador(a) de Manufactura de Parenterales
Salario: Comenzando en $15ph
Responsabilidades principales:
Realizar actividades relacionadas con la preparación y operación de equipos, cambios de línea, limpieza y liberación de áreas, para asegurar una operación eficiente y maximizar el rendimiento del producto.
Operar equipos de preparación, formulación y llenado, así como realizar actividades básicas de solución de problemas.
Limpiar, sanitizar y esterilizar áreas y equipos, ejecutando procesos CIP y SIP en tanques y autoclaves.
Recibir, pesar y verificar excipientes y principios activos; ejecutar la formulación de productos según instrucciones de Batch Record y Procedimientos.
Monitorear parámetros críticos del proceso, asegurar el cumplimiento de calibraciones y realizar pruebas de integridad en filtros y sistemas.
Completar y auditar documentación de producción conforme a Buenas Prácticas de Documentación (GDP).
Mantener inventarios de materiales y solicitar insumos necesarios.
Participar en la resolución de investigaciones de calidad, capacitaciones internas y proyectos especiales.
Apoyar en actividades de monitoreo ambiental, validaciones y cumplimiento de programas regulatorios.
Cumplir con las regulaciones de cGMP, Seguridad y Medio Ambiente, incluyendo manejo de residuos peligrosos y no peligrosos.
Requisitos:
Escuela Superior, mínimo 2 años de experiencia en procesos parenterales, o 3 años en la industria farmacéutica.
Disponibilidad para trabajar turnos diurnos o nocturnos de 12 horas.
Conocimientos en procesos de preparación, formulación, llenado, esterilización, liofilización y tecnología de aisladores.
Comprensión y manejo de equipos automatizados y sistemas computarizados (HMI, PLC).
Habilidad para trabajar bajo mínima supervisión y para capacitar a nuevos empleados.
Excelente atención al detalle, habilidades organizacionales y capacidad para documentar de forma clara y precisa.
Conocimientos en cGMP, seguridad, EHS y manejo de documentación.
Capacidad para leer procedimientos en inglés y español.
Habilidades matemáticas básicas y destreza para inspecciones visuales.
Trabajo en equipo, liderazgo, responsabilidad y compromiso.
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