Technical Quality Compliance Specialist

Supervise and coordinate validation and qualification activities, ensuring the correct execution of protocols and the continuous maintenance of the validated state of equipment, systems, processes, and applications, in compliance with current regulatory requirements and ROVI PhIS corporate standards.

Lead and support equipment and system qualification activities, participating in the review and approval of associated documentation (URS, DQ, IQ, OQ, and PQ) and ensuring its execution in accordance with the established schedule.

Review and approve validation documentation for automated systems and GxP equipment, including protocols, execution evidence, and final reports, ensuring data integrity and compliance with applicable regulations.

Manage the review of documentation related to computerized systems and LIMS (Laboratory Information Management System), assessing changes, configurations, validations, access controls, data integrity, and associated documentation to ensure alignment with regulatory expectations.

Perform the review and monitoring of Audit Trail, Performance Monitoring, and other activities related to Data Integrity, identifying risks, proposing improvement actions, and ensuring the traceability of critical information.

Evaluate and review analytical methods and their associated documentation, participating in validation, transfer, verification, and maintenance activities of the validated state of methods used in the laboratory.

Analyze and monitor microbiological trends and other quality indicators, identifying deviations, behavioral patterns, and opportunities for improvement that contribute to strengthening the microbiological control and environmental monitoring strategy.

Ensure that all documentation and validation, qualification, and analytical control activities comply with GMP, GAMP, 21 CFR Part 11, Annex 11 of EU GMP, and the company's internal procedures.

Actively participate in investigations, incident management, deviations, and risk analyses related to validation, qualification, computerized systems, and laboratory activities, providing technical solutions that ensure the quality, safety, and efficacy of products manufactured by the ROVI Group.

Act as a technical reference and collaborate cross-functionally with the Quality, Production, Engineering, IT, and Laboratory areas, driving continuous improvement, operational excellence, and regulatory compliance.

• Direct participation in strategic validation, digitalization, and process improvement projects.
• Interaction with multidisciplinary teams and advanced technologies in the pharmaceutical environment.
• Opportunity to contribute to the quality and safety of high-impact medicines for patients.
• Dynamic environment oriented toward innovation, technical excellence, and continuous professional development.

The experience for this job is:

From 1 to 2 years

The required education for the job is:

Bachelors Degree: Biology (mandatory), Bachelors Degree: Chemical (mandatory), Bachelors Degree: Pharmacy (mandatory), Masters Degree: Pharmacy

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.

Supervisar y coordinar las actividades de validación y cualificación, asegurando la correcta ejecución de protocolos y el mantenimiento continuo del estado validado de equipos, sistemas, procesos y aplicaciones, en cumplimiento con los requisitos regulatorios vigentes y los estándares corporativos de ROVI PhIS.

Liderar y dar soporte a las actividades de cualificación de equipos y sistemas, participando en la revisión y aprobación de la documentación asociada (URS, DQ, IQ, OQ y PQ) y garantizando su ejecución conforme a la planificación establecida.

Revisar y aprobar la documentación de validación de sistemas automatizados y equipos GxP, incluyendo protocolos, evidencias de ejecución e informes finales, asegurando la integridad de los datos y el cumplimiento de las normativas aplicables.

Gestionar la revisión de documentación relacionada con sistemas informatizados y LIMS (Laboratory Information Management System), evaluando cambios, configuraciones, validaciones, controles de acceso, integridad de datos y documentación asociada para garantizar su adecuación a las expectativas regulatorias.

Realizar la revisión y seguimiento de Audit Trail, Performance Monitoring y otras actividades vinculadas a Data Integrity, identificando riesgos, proponiendo acciones de mejora y garantizando la trazabilidad de la información crítica.

Evaluar y revisar métodos analíticos y su documentación asociada, participando en actividades de validación, transferencia, verificación y mantenimiento del estado validado de los métodos utilizados en laboratorio.

Analizar y realizar seguimiento de tendencias microbiológicas y otros indicadores de calidad, identificando desviaciones, patrones de comportamiento y oportunidades de mejora que contribuyan al fortalecimiento de la estrategia de control microbiológico y de monitorización ambiental.

Garantizar que toda la documentación y actividades de validación, cualificación y control analítico cumplen con las normativas GMP, GAMP, 21 CFR Part 11, Anexo 11 de las GMP de la UE y los procedimientos internos de la compañía.

Participar activamente en investigaciones, gestión de incidencias, desviaciones y análisis de riesgos relacionados con validación, cualificación, sistemas informatizados y actividades de laboratorio, aportando soluciones técnicas que aseguren la calidad, seguridad y eficacia de los productos fabricados por el Grupo ROVI.

Actuar como referente técnico y colaborar de manera transversal con las áreas de Calidad, Producción, Ingeniería, IT y Laboratorios, impulsando la mejora continua, la excelencia operacional y el cumplimiento regulatorio.

• Participación directa en proyectos estratégicos de validación, digitalización y mejora de procesos.
• Interacción con equipos multidisciplinares y tecnologías avanzadas del entorno farmacéutico.
• Oportunidad de contribuir a la calidad y seguridad de medicamentos de alto impacto para los pacientes.
• Entorno dinámico orientado a la innovación, la excelencia técnica y el desarrollo profesional continuo.

The experience for this job is:

From 1 to 2 years

The required education for the job is:

Bachelors Degree: Biology (obligatorio), Bachelors Degree: Chemical (obligatorio), Bachelors Degree: Pharmacy (obligatorio), Masters Degree: Pharmacy

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.