Validation Supervisor

hace 3 semanas

León, España PCI Pharma Services A tiempo completo

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

La funcion

La persona selecionada tiene como funciones principales contribuir para la formación y desarrollo profesional de personal a su cargo en colaboración con el responsable del departamento y gestionar el personal a su cargo, asignándolos a los diferentes proyectos en función de las necesidades y supervisando directa o indirectamente las tareas.

**Responsabilidades**:
- Elaborar, revisar y aprobar Procedimientos Normalizados de Trabajo siguiendo las normativas GMP.- Elaborar, revisar y aprobar documentación GMP específica de su sección.- Colaborar en la elaboración de documentación técnica relacionada con los productos fabricados (dosieres, acuerdos de calidad, etc.).- Implantar y verificar la aplicación de las GMP.- Control y archivo de documentación, datos y registros generados.- Gestionar y revisar eventos de calidad (incidencias, desviaciones, controles de cambios, acciones correctivas y preventivas, resultados fuera de especificaciones) así como participación en investigaciones de causa raíz y aprobación de planes de implantación.- Colaboración en la gestión de quejas y/o reclamaciones de clientes.- Realizar auditorías internas/externas de Calidad.- Participar en las auditorías de clientes e inspecciones de autoridades sanitarias.- Elaborar, revisar y aprobar los Informes anuales de producto.- Elaboración y/o revisión del Plan Maestro de Validaciones y los planes de Calibraciones, verificaciones y recualificaciones anuales.- Elaboración, ejecución y/o revisión de los protocolos e informes de cualificación y validación de equipos, sistemas y servicios.- Redacción y/o revisión de documentación técnica relacionada con las instalaciones: Site Master File, cartas de deficiencias, módulos aplicables al dosier de registro.- En coordinación con los responsables de cada área gestionar y supervisar las calibraciones, verificaciones y mantenimiento de las instalaciones, equipos y servicios.- Nível de ingles alto- Experiência de al menos 5 años en puesto similar- Capacidad para interaccionar con clientes

Requisitos- Grado en Farmacia, Química, Biología o similar.- Experiência en un puesto similar.- Experiência en validaciones asociadas al equipo.- Conocimientos de cualificación en sistemas de calidad.- Experiência con sistemas aisladores (preferencial).- Nível B2 de inglés y español requerido para el cargo.

Beneficios

En PCI, creemos que nuestros empleados son nuestro activo más valioso. Por eso, estamos comprometidos a ofrecer un paquete de beneficios diseñado para apoyar tu bienestar y mejorar tu calidad de vida.

Esto es lo que ofrecemos:
- Salario competitivo- Seguro de salud + reembolso de medicamentos- Clases de inglés- Descuentos en diversas actividades- Convenios con gimnasios- Programa de recomendación

LI-AT1

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
- At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._

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