Quality Oversight Specialist

• Monitoring and implementation of programs, procedures, and practices in areas intended for the manufacture of medications by aseptic filling, under the criteria of compliance with GMP and ROVI internal policy.
• Supervision of good practices in the production plant under the criteria of compliance with GMP.
• Monitoring of material sterilization processes and control of equipment use under current qualification guidelines, monitoring of cleanliness of areas and equipment, and monitoring of personnel gowning procedures.
• Supervising, in person or remotely, the aseptic filling validation processes of the production plant.
• Reviewing media fill events, in person or remotely, through video review.
• Monitoring of aseptic practices and CCS, with participation in meetings and work sessions as established.
• Drafting, reviewing, and approving procedures related to pharmaceutical activity in general (manufacturing, quality, etc.) under the criteria of compliance with GMP and ROVI internal policy.
• Providing or participating in personnel training related to quality criteria in pharmaceutical operations.
• Participation in audits, collaborating with quality criteria aligned with EU GMP and reference guidelines.
• Notifying higher positions of potential compliance risks detected during routine functions and proposing improvements regarding them.
• Implementing and closing CAPAs and CHCs for which responsible, within the estimated timeframe.
• Walkthroughs of the production plant, reporting observations and creating an oversight panel.
• Technical assistance, monitoring, review, and active collaboration in resolving incidents or deviations that could lead to alterations or risks to the quality, safety, and efficacy of medications.
• Sampling and analysis of commercial units for inspection of quality defects (AQL).

The experience for this job is:

From 1 to 2 years

The required education for the job is:

Bachelor's Degree

Your contract type will be:

Temporary (fixed-term)

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.

• 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 colaborando con criterios calidad alineados a 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 y proponer mejoras ante estos.
• 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.
• Muestreo y análisis de unidades comerciales para inspección de defectos de calidad (AQL)

The experience for this job is:

From 1 to 2 years

The required education for the job is:

Bachelors Degree

Your contract type will be:

Temporary (duración determinada)

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.