QA Investigations Technician
This job was originally posted in Spanish and automatically translated to English. You'll most likely need Spanish to apply.
Job Description
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?
Collaborate in compliance with Good Manufacturing Practices. Ensure compliance with the company's Quality System, together with the rest of the department.
Manage and coordinate product inquiries and complaints received according to internal procedures. Follow up, review, and approve investigations derived from deviations and complaints, and inform the other assigned areas. Review and approve investigations for alert and specification limit exceedances derived from water and steam systems.
Coordinate the creation, execution monitoring, closure, and effectiveness evaluation of CAPAs according to internal procedures.
Participate as part of the research team in applicable investigations. Report the necessary data for the generation of quality reports and metrics for the systems/processes in your area. Drafting and review of department procedures.
Provide support and participation in audits and self-inspections. Provide support with the necessary data for the preparation of APRs.
Your contract type will be:
Temporary (duración determinada)The required education for the job is:
Bachelors Degree: Chemical, Bachelors Degree: PharmacyThe experience for this job is:
From 1 to 2 yearsView original advert (Spanish)
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?
Colaborar con el cumplimiento de las Normas de Correcta Fabricación. Velar por el cumplimiento del Sistema de Calidad de la compañía, conjuntamente con el resto del departamento.
Gestionar y coordinar las consultas y reclamaciones de producto recibidas según el procedimiento interno. Hacer seguimiento, revisar y aprobar las investigaciones derivadas de desviaciones y reclamaciones, e informar al resto de áreas asignadas. Revisar y aprobar las investigaciones por superaciones de límites de alerta y de especificación derivadas de los sistemas de agua y vapor.
Coordinar el alta, seguimiento de ejecución, cierre y evaluación de la eficacia de las CAPA según el procedimiento interno.
Participar como parte del equipo investigador en las investigaciones aplicables. Reportar los datos necesarios para la generación de informes y métricas de calidad de los sistemas/procesos de su área. Realización y revisión de procedimientos del departamento.
Dar apoyo y participación en auditorias y autoinspecciones. Dar apoyo con los datos necesarios para la preparación de los APRs.
Your contract type will be:
Temporary (duración determinada)The required education for the job is:
Bachelors Degree: Chemical, Bachelors Degree: PharmacyThe experience for this job is:
From 1 to 2 years