QA Senior Quality System

Leanbio S.L.; Almería; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

Una empresa líder en la biotecnología busca un nuevo Técnico de Aseguramiento de Calidad para unirse a su equipo en unas instalaciones modernas en Sant Quirze del Vallès. Este rol es crucial para garantizar la calidad en las actividades de fabricación bajo estándares GMP, incluyendo la gestión de sistemas de calidad, la calificación de proveedores y la revisión de documentación. Se requiere título en ciencias y experiencia en GMP, así como habilidades analíticas y comunicativas en español e inglés.

Formación

• Experiencia comprobada en rol de Aseguramiento de Calidad en ambientes GMP.
• Conocimientos en gestión de desviaciones y controles de cambio.
• Habilidades analíticas y organizativas sobresalientes.

Responsabilidades

• Construir y gestionar el Sistema de Gestión de Calidad supervisado por el Responsable de Aseguramiento de Calidad.
• Liderar el programa de calificación de proveedores, aprobando nuevos proveedores.
• Revisar la documentación de lotes para propósitos de liberación.

Conocimientos

Gestión de Sistemas de Calidad

Resolución de Problemas

Comunicación Verbal y Escrita

Educación

Título Universitario 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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