Assoc. Spclst, Quality Assurance

hace 5 meses

Bogota, Colombia Merck A tiempo completo

**Descripción del Puesto/de la Posición**

La persona será encargada de dar soporte al área de In Market Quality con el fin de mantener un sistema de calidad efectivo y alineado a regulaciones locales y Procedimientos globales corporativos.

**Responsabilidades**
- Soporte en el desarrollo y mantenimiento del sistema de gestión de calidad local para asegurar con cumplimiento de regulaciones locales y guías de la compañía
- Apoyo en la liberación local de productos de acuerdo a regulaciones del mercado y guías globales.
- Soporte en la Administración de SOPs locales, garantizando los mismos estén al día y sus actualizaciones sean realizadas en tiempo.
- Soporte en la Administración de la matriz de entrenamiento, y programa a anual de entrenamiento garantizando el entrenamiento en tiempo del personal.
- Apoyo y coordinación de actividades locales asociadas a manejo de Complaints (PQCs) de productos.
- Seguimiento de CAPAS y/o compromisos adquiridos provenientes de: Desvios, controles de cambios, auditorías, reuniones de calidad, etc.
- Dar soporte a actividades locales asociadas al retiro de producto del mercado (Recall) de ser necesario.
- Ayuda y soporte en la supervisión del centro de distribución local asegurando cumplimiento del acuerdo de calidad.
- Apoyo en la investigación de desviaciones detectadas en productos o documentos durante los procesos de embarque, almacenamiento, y distribución en el mercado local
- Soporte en el manejo adecuado de la cadena de frio.
- Revisión mensual de registros de temperatura del 3PL y levantar detección de no conformidades asociadas.
- Soporte de buenas prácticas de distribución para el desarrollo del negocio en el mercado local

**Educación, Experiência y Habilidades Requeridas**
- Profesional de Química Farmacéutica, química o afines,
- Experiência de mínimo 1 año en industria Farmacéutica o afín.
- Conocimiento en: Buenas Prácticas de Manufactura, Buenas Prácticas de Almacenamiento, Buenas Prácticas de Distribución y/o Buenas Prácticas de Documentación
- Habilidades personales: Responsabilidad y autogestión; Proactividad y capacidad de rápido aprendizaje para crear y proponer; Orientación a los detalles; Planificación y organización; Disciplina y manejo del tiempo; Trabajo en equipo

**Educación, Experiência y Habilidades Deseables**
- Manejo intermedio del paquete office (énfasis en Word, SharePoint, Power Point)
- Manejo de Ingles (Medio o Avanzado)

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Annualized Salary Range (Canada)**

**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R525621

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