QA Senior Quality System

Leanbio S.L.; Ourense; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Una empresa biopharma líder busca un Técnico de Aseguramiento de Calidad para unirse a su nuevo sitio en Sant Quirze del Vallès. Las tareas incluyen la gestión del sistema de calidad y la calificación de proveedores en un entorno GMP. Se valora la experiencia previa y habilidades en comunicación, así como una sólida formación en Ciencias.

Formación

• Experiencia en roles de Aseguramiento de Calidad GMP.
• Conocimiento en sistemas de gestión de calidad (desviaciones, CAPA, controles de cambios).
• Experiencia en calificación de instalaciones y equipos.

Responsabilidades

• Desarrollar y gestionar el Sistema de Gestión de Calidad.
• Liderar el programa de calificación de proveedores.
• Revisar la documentación técnica para la liberación de lotes.

Conocimientos

Resolución de problemas

Toma de decisiones

Habilidades comunicativas

Analítica

Organización

Educación

Licenciatura en Ciencias

Descripción del empleo

Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in the field of recombinant proteins, mRNA and pDNA. With over a decade of expertise, we have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA and pDNA.

Leanbio has already worked with over 100 candidates over these years, some already in late clinical stages. Leanbio is expanding its development and manufacturing capabilities with a new GMP site in Barcelona with over 4,000 sqm. and three manufacturing areas : one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third are for mRNA up to 50L.

The new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a global service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do :

• Providing cutting-edge end-to-end services.
• Offering extensive expertise in biologics.

We are looking for a new person to join the QA as a Technician to work in our brand new facilities in Sant Quirze del Vallès :

MAIN RESPONSIBILITIES :

• To build, with the Head of Quality Assurance oversight, the Quality Management System creating and / or approving Standard Operating Procedures to support GMP manufacturing activities.
• To build and manage the Documentation Management System and associated training.
• To lead the supplier qualification program, approving new suppliers and managing supplier status during its life cycle.
• To review Technical Agreements between the company and suppliers / clients.
• To review batch documentation for release purposes.
• To support facility, utilities and equipment qualification activities, approving protocols and final reports as well as managing related change control records.

REQUIREMENTS :

• Bachelor’s degree in a Science field with proven experience in GMP Quality Assurance roles
• In-depth knowledge managing Quality Management Systems (deviations, CAPA, change controls, audits and supplier qualification).
• Experience in batch release activities acting as QP deputy will be a plus
• Experience in facilities, utilities and equipment qualification.
• Outstanding problem-solving and decision-making skills.
• Team player, excellent verbal and written comunication skills (both Spanish and English) and strong analytical and organizatonal skills.

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