Data integrity Expert
Pilar, Argentina Permanent Posted on Jan. 14, 2025 Closing on Jan. 29, 2025Data Integrity Expert
- Ubicación: Pilar – Buenos Aires Argentina
- Tipo de empleo: Permanente / tiempo completo
Acerca del rol
- Establecer y priorizar los objetivos de integridad de datos para el sitio (D)
- Identificar de manera proactiva las acciones de remediación a partir de los hallazgos de las auditorías internas y externas (A)
- Identificar las necesidades de capacitación y el contenido para la integridad de datos (D)
- Decidir las acciones correctivas y preventivas para los problemas de integridad de datos (D)
- Asesorar sobre las estrategias de integridad de datos interdepartamentales (A)
- Recibir información sobre los resultados de las inspecciones y auditorías (I)
- Recibir información sobre cualquier violación de la integridad de datos (I)
- Garantizar el cumplimiento de los requisitos regulatorios y las políticas de la empresa relacionadas con la integridad de datos.
- Realizar controles y validaciones de calidad de datos de rutina para identificar y abordar cualquier problema de integridad de datos.
- Desarrollar y ofrecer programas de capacitación sobre los principios y prácticas de integridad de datos.
- Identificar y evaluar los riesgos relacionados con la integridad de los datos e implementar estrategias de mitigación.
- Garantizar que se sigan las prácticas de documentación adecuadas, incluido el registro, el almacenamiento y la recuperación de datos.
- Investigar los incidentes de integridad de datos, incluidas las posibles violaciones de datos o incidentes de falsificación, e implementar acciones correctivas y preventivas (CAPA).
- Liderar iniciativas de mejora continua para mejorar las prácticas de integridad de datos. • Supervisar la validación de los sistemas informáticos para garantizar que cumplan con los requisitos de integridad de datos.
- Garantizar la preparación para la inspección y participar en inspecciones y auditorías regulatorias relacionadas con la integridad de datos.
- Generar y revisar informes y métricas de integridad de datos para la administración, especialmente el DIMM (modelo de madurez de DI)
- Ser representante del sitio en la CoP liderada por el global y, si se lo solicita, participar en el CoE y garantizar la comunicación local.
- Participar en las actividades relacionadas a los Sistemas de Calidad liderados por el área de Sistemas de Calidad & Compliance.
Acerca de tí
- Experience: Al menos 5 años de experiencia garantizando el cumplimiento de los requisitos regulatorios relacionados con la integridad de los datos en la industria farmacéutica.
- Competencias: Capacidad para analizar conjuntos de datos complejos e identificar patrones, discrepancias y áreas de mejora; Alto nivel de precisión y atención al detalle en el registro, la auditoría y la elaboración de informes de datos; Sólidas habilidades de comunicación verbal y escrita para capacitar al personal de manera eficaz, informar los hallazgos y colaborar con varios departamentos; Competencia en la identificación de las causas fundamentales de los problemas de integridad de los datos, y en el desarrollo de acciones correctivas y preventivas eficaces; Experiencia en el uso y la validación de sistemas informáticos y software relevantes para la gestión de la integridad de los datos.
- Idioma: Manejo del idioma ingles avanzado
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