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Senior Validation Consultant

hace 3 meses

Barcelona, Barcelona, España Ambit BST A tiempo completo
Te invitamos a unirte a nuestro equipo de Pharma&Biotech como
Senior Validation Consultant. En este rol, tendrás la oportunidad de sumergirte en proyectos, auditorías y formaciones extremadamente interesantes.


Si buscas contribuir con tu experiência en un equipo innovador y participar en iniciativas que marquen la diferencia, esta oportunidad es para ti.


RESPONSABILIDADES:

  • Planificar y dirigir los proyectos asignados, según los requisitos del cliente y los requisitos legales aplicables, para conseguir los objetivos estratégicos de la compañía.
  • Planificar y organizar el proyecto con el cliente y el equipo.
  • Resolver consultas de los técnicos, consultores y clientes, así como revisar documentación de validación (CSV).
  • Controlar los recursos (personas y presupuesto) asignados al proyecto.
  • Evaluación del cumplimiento de los sistemas informatizado con respecto a los principios de integridad de los datos.
  • Realización de formaciones (internas y externas).
  • Realización de auditorías (GMP, GDP)

HABILIDADES:

  • Estudios universitarios con postgrado o Máster (Ingeniería Química, Ingeniería Industrial, Química, Biología, Biotecnología)
  • Experiência profesional de más de 5 años
  • Experiência en la validación de sistemas informatizados.
  • Conocimiento de las GxP (GMP, GLP, GCP, GDP) del sector farmacéutico.
  • Experiência en la realización de pruebas para el cumplimiento de 21 CFR Part 11 y EU GMP Annex 1
  • Conocimiento en Data Integrity y GAMP
  • Realización de auditorías (GMP, GDP)
  • Habilidades comunicativas.
  • Inglés alto.
Disponibilidad para viajar puntualmente a nível nacional e internacional.

Carné de conducir y vehículo propio.

HORARIO:

  • Flexible de 08/09h a 17/18h (De lunes a viernes)
  • Híbrido: 2 días presencial y 3 en remoto.
  • Ubicación: Barcelona

CONDICIONES:

  • Contrato indefinido.
  • Salario negociable.
  • Ticket restaurante los días que vayas a la oficina.
  • Plan de retribución flexible (libre de IRPF), ponemos a tu disposición: seguro médico privado, billete de transporte público y cheque guardería.
  • Descuentos en la red de gimnasios (AJ by Gympass)
  • Formación y desarrollo.
  • Bonus referral por referenciar a una persona que cumpla con el perfil que buscamos. Tu recomendación es garantía extra de calidad