Especialista Tecnico Quality Oversight

hace 1 semana

JULIAN CAMARILLO MADRID, España Rovi A tiempo completo

What do we do?

We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products.

We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals.

All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.

What will you do?

  • Seguimiento e implementación de programas, procedimientos y prácticas en zonas destinadas a la fabricación de medicamentos por llenado aséptico, bajo el criterio de cumplimiento de las NCF y política interna de ROVI.
  • Supervisión de las buenas prácticas en planta productiva bajo el criterio de cumplimiento de las NCF.
  • Vigilancia de procesos de esterilización de materiales y control de uso de equipos bajo pautas de cualificación vigentes, vigilancia de la limpieza de áreas y equipos y vigilancia de operatoria de vestimenta de personal.
  • Supervisar de forma presencial o remota los procesos de validación de llenado aséptico de la planta productiva.
  • Revisión de eventos de media fills test, de forma presencial o remota mediante el estudio de vídeos.
  • Vigilancia de prácticas asépticas y CCS, con la participación en reuniones y jornadas de trabajo que se establezcan para ello.
  • Elaborar, revisar y aprobar procedimientos vinculados a la actividad farmacéutica en general (fabricación, calidad, etc.) bajo el criterio de cumplimiento de las NCF y política interna de ROVI.
  • Impartir o participar en la formación de personal vinculado a criterios de calidad en la operatoria farmacéutica.
  • Participación en auditorías internas colaborando con criterios calidad alineados al anexo 15 de las GMP EU y guías de referencia internacionales. 
  • Notificar a los puestos superiores de potenciales riesgos de incumplimiento que sean detectados en la realización de las funciones de rutina.
  • Implementar y cerrar las CAPAs y CHCs de las que sea responsable en el plazo estimado.
  • Walktrought en planta productiva, reporte de observaciones y creación de panel oversight.
  • Asistencia técnica, seguimiento, revisión y colaboración activa en la resolución de incidencias o desviaciones y puedan suponer alteraciones o riesgos para la calidad, seguridad y eficacia de medicamentos y productos sanitarios fabricados por Grupo ROVI.
  • Muestreo y análisis de unidades comerciales para inspección de defectos d calidad (AQL)

Your contract type will be:

Temporary (Fixed Term)

The required education for the job is:

Technical Certification

The experience for this job is:

From 1 to 2 years

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