Qualified Person

hace 3 semanas

Barcelona, España Novartis A tiempo completo

El Qualified Person (QP) garantiza que los medicamentos en investigación clínica y medicamentos comerciales puestos en el mercado cumplen con los requisitos de fabricación, análisis y distribución en entorno GMP, según la legislación vigente.

**Tus responsabilidades sin límites**:

- Como parte fundamental de la cadena de suministro, asegurar la calidad de los productos comerciales puestos en el mercado. Responsable de la liberación de los productos y de que los medicamentos comercializados en España hayan sido fabricados y analizados según la legislación vigente, en conformidad con las GMPs y la Autorización de comercialización.
- Garantizar la creación de las QPs Declaracions y la revisión de los PQR en el momento oportuno.
- Gestionar los incidentes y las emergencias relacionados con los productos de forma oportuna y eficaz para garantizar el mantenimiento del suministro de productos críticos.
- Participar en las reuniones de escalados globales y liderar los comités locales, cuando sea necesario, para evaluar los impactos locales y/o implementar las decisiones. Servir de enlace con todas las partes interesadas. Gestionar retiradas de producto comercial, si fuera necesario.
- Actuar como responsable ante las Autoridades Sanitarias y ante terceros sobre la Calidad de los Medicamentos.
- Gestionar desviaciones, y Gestionar actividades de revisión, manipulación y acondicionamientos locales.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**Requisitos obligatorios**:

- Título de formación universitaria en Farmacia u otra licenciatura equivalente, siempre que sea aprobado y validado por la AEMPS.
- 5 años de experiência en Industria Farmacéutica, en Fabricación, QA y QC.
- Experiência en puesto similar como Qualified Person QP
- Alto conocimiento de las GMPs y sistemas de Garantía de Calidad
- Capacidad de liderazgo y gestión de equipo directo o indirecto
- Español nativo y Inglés nível alto escrito y oral

**¿Qué te ofrecemos?**
- Salario competitivo (salario fijo + bonus anual)
- Un amplio abanico de beneficios sociales: plan de pensiones, seguro médico gratuito, cantina con menú parcialmente subvencionado, seguro de vida y accidentes, descuentos en plataformas de gimnasio y salud, plataforma virtual de descuentos, ayudas económicas, permisos ampliados, y mucho más
- Un entorno dinámico en el que aprender y desarrollarte:

- Cursos de inglés y plataforma con un catálogo extenso de formaciones internas.
- Programas de formación y desarrollo en liderazgo para Managers

**Division**

Operations

**Business Unit**

QUALITY

**Country**

Spain

**Work Location**

Barcelona Gran Vía

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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