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Quality Assurance Technician
hace 4 meses
Fecha: 22 nov. 2023- Ubicación: SAB0 - PHARMA SANT ANDREU DE L**Misión**:
Asegurar que los Sistemas de Calidad de las plantas farmacéuticas de producción cumplen con las GMPs y las políticas de Calidad Corporativas de Almirall con el fin de garantizar la seguridad, eficacia y calidad de sus productos farmacéuticos.
**Funciones y responsabilidades**:
- Aprobar la documentación operativa para la fabricación y control de productos farmacéuticos.
- Revisar la documentación generada en los procesos de la planta verificando su correcta adecuación y cumplimentación.
- Realizar auditorías periódicas para verificar el nível de cumplimiento de las GMP en los procesos de fabricación y control de la planta.
- Evaluar los cambios desde el punto de vista de afectación sobre la calidad del producto y respecto el nível de compliance de las GMP. Aprobar todos los cambios y someter a aprobación adicional del QA Mánager aquéllos evaluados como significativos.
- Participar en la investigación de las desviaciones de proceso respecto a los estándares definidos, así como en las reclamaciones del mercado por motivos de calidad. Someter a aprobación del QA Mánager toda desviación evaluada como significativa o reclamación procedente.
- Efectuar el seguimiento de las medidas correctivas y preventivas.
- Revisar la globalidad de registros que componen el Batch Manufacturing Record para la liberación al mercado por parte de la Dirección Técnica Farmacéutica.
- Supervisar el cumplimento de las normas de seguridad y medioambiente por parte de los colaboradores en su ámbito de responsabilidad, así como identificar situaciones o actuaciones que puedan implicar un riesgo en los procesos.
**Formación**:
Licenciatura en Farmacia, Química, o afín.
**Conocimientos específicos**:
- Conocimientos específicos de GMP’s.
- Inglés Avanzado.
**Experiência**:
Experiência profesional de 1 año en QA, producción y/o control de calidad en ámbito químico-farmacéutico.
**Valores y competencias**:
Valores:
- Care
- Courage
- Innovation
- Simplicity
