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Quality Assurance Manager

hace 4 meses


SAB PHARMA SANT ANDREU DE L, España Almirall A tiempo completo
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 nivel de cumplimiento de las GMP en los procesos de fabricación y control de la planta.

• Realizar auditorías frente a unidades sanitarias y/o partners así como onflor.

• Evaluar los cambios desde el punto de vista de afectación sobre la calidad del producto y respecto el nivel 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.

Información Adicional:

Posición indefinida

GP - 6

Turno central

Formación

Grado en Farmacia

Conocimientos específicos


• Conocimientos específicos de GMP's.

• Conocimientos de Normativa FDA-CFR21

• Conocimientos de sistema Trackwise

• Conocimientos de sistema EDMS

• Inglés avanzado

Experiencia
  • Experiencia mínima de 2 años en QA en un entorno de producción en industria químico-farmacéutica.
  • Valorable experiencia previa como Qualified Person.
Valores


• Care: escuchamos y sentimos empatía, valoramos las diversas perspectivas y orígenes y nos ayudamos mutuamente a tener éxito.

• Courage: desafiamos el status quo, asumimos la responsabilidad total y aprendemos de nuestros éxitos y fracasos.

• Innovation: ponemos al paciente y al cliente en el centro, creamos soluciones novedosas y potenciamos mentalidades emprendedoras.

• Simplicity: actuamos con decisión y evitamos el análisis excesivo, entendemos por qué antes de actuar y somos ágiles y mantenemos las cosas simples.