Quality Compliance Assurance Technician

Carry out department activities to comply with GMPs, the company's Quality System.

Ensure compliance with the company's Quality System, jointly with the responsible person.

Perform and/or collaborate on internal audits as applicable, according to specific procedures.

Actively participate in the preparation of client audits. Coordinate and manage the Rovi PhIS Change Control system.

Follow up on actions derived from internal and external audits.

Manage and coordinate CAPAs suggested in the quality systems.

Implement and close the CAPAs for which they are responsible within the estimated timeframe.

Collaborate in the implementation of the continuous improvement program and establish quality metrics for systems/processes.

Knowledge of medical device legislation and applicable standards.

Management of supplier complaints.

Management of the Site Master File.

Management and participation in the supplier qualification process.

Management of annual product evaluations. PQR.

Coordinate and review quality agreements with clients and suppliers.

Regulatory support to the registrations area on quality compliance matters.

Collaborate in the company's data integrity program.

The required education for the job is:

Bachelor's Degree (mandatory).

The experience for this job is:

Your contract type will be:

Indefinite

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.

Realizar las actividades del departamento para cumplir las GMPs, el sistema de Calidad de la compañía.

Velar por el cumplimiento del Sistema de Calidad de la compañía, conjuntamente con el responsable.

Realizar y/o colaborar en las auditorías internas que procedan, según los procedimientos específicos.

Participar activamente en la preparación de auditorías de clientes. Coordinar y gestionar el sistema de Control de cambios de Rovi PhIS.

Seguimiento de las acciones derivadas de auditorías internas y externas.

Gestión y coordinación de CAPAs sugeridas en los sistemas de calidad.

Implementar y cerrar las CAPAs de las que es responsable en el plazo estimado.

Colaborar en la implantación del programa de mejora continua y establecer métricas de calidad de los sistemas/procesos.

Conocimientos en legislación de productos sanitarios y normas aplicables.

Gestión de reclamaciones de proveedores.

Gestión de Site Master File.

Gestión y participación en el proceso de cualificación de proveedores

Gestión de las evaluaciones anuales de producto. PQR.

Coordinar y revisar los acuerdos de calidad con los clientes y proveedores.

Soporte regulatorio al área de registros en temas de compliance de calidad

Colaborar en el programa de integridad de datos de la compañía.

The required education for the job is:

Bachelors Degree (obligatorio)

Your contract type will be:

Indefinite

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.