Técnico / a Financiero / a

UpBizor | Tu Partner Financiero; Madrid; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa líder en la fabricación de Ingredientes Farmacéuticos Activos busca un Auditor de Cumplimiento de Calidad. Esta posición clave implica asegurar el cumplimiento de normativas GMP y FDA, gestionar auditorías internas y externas, y colaborar con equipos multifuncionales para mejorar la calidad y la documentación. Si tienes una mentalidad orientada a los detalles y una pasión por la mejora continua, esta es tu oportunidad para unirte a un equipo innovador y contribuir al futuro de la fabricación farmacéutica. ¡Aplica ahora y forma parte de un entorno dinámico y colaborativo!

Formación

• Mínimo 2 años de experiencia en Aseguramiento de Calidad o Cumplimiento de GMP.
• Fuerte comprensión de las directrices de GMP y principios de Integridad de Datos.

Responsabilidades

• Asegurar el cumplimiento de las normativas GMP de la UE y la FDA en operaciones de fabricación.
• Gestionar auditorías internas y externas, así como la calificación de proveedores.

Conocimientos

Cumplimiento de GMP

Auditoría interna

Documentación técnica

Resolución de problemas

Atención al detalle

Educación

Licenciatura en Farmacia

Licenciatura en Química

Licenciatura en Biotecnología

Licenciatura en Ciencias de la Vida

Herramientas

SOPs

Documentación de auditoría

Descripción del empleo

Company overview :

With over 85 years of experience, UQUIFA Group is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, serving the pharmaceutical and animal health industries worldwide. Operating under cGMP conditions, our two manufacturing sites in Spain and Mexico have been inspected and approved by leading global pharmaceutical companies and regulatory authorities, including the US FDA. Since 2018, Soneas Chemicals Ltd., a Budapest-based company focused on CDMO activities, has been part of the UQUIFA Group, enhancing our capabilities in route scouting, process optimization, and both small- and large-scale manufacturing. Our commitment to innovation, quality, safety, passion, environmental sustainability, and flexibility drives us to deliver excellence to our clients in over 70 countries.

Our plant in Sant Celoni is looking to hire a QA Compliance Auditor.

Responsibilities:

• Ensure compliance with EU GMP, FDA 21 CFR Part 210 / 211, ICH Q7, and Data Integrity (ALCOA++ principles) in manufacturing operations.
• Oversee and review GMP documentation, including Standard Operating Procedures (SOPs), batch records, and technical reports.
• Provide support to manufacturing and packaging processes to address any compliance issues.
• Own internal audits, regulatory inspections (FDA, EMA, local authorities), and customer audits. Responsible for the management of external audits of customers, internal audits, and supplier audits as part of the supplier qualification program, serving as the primary point of contact for customers and the commercial team regarding general quality issues.
• Ensure timely implementation and follow-up of CAPAs from audits and regulatory observations including preparation and review of the CAPA Plan, liaising with relevant departments to ensure improved GMP compliance.
• Own supplier qualification processes, including documentation review and compliance verification.
• Manage quality questionnaires, including creating and updating company-wide and customer-specific quality questionnaires.
• Fully own and maintain the external audit calendar.
• Organize audit agendas, escort auditors, coordinate internal staff, and communicate audit results.
• Define and update audit work procedures, as well as company presentation documentation.
• Execute internal audits / self-inspections and supplier audits in collaboration with qualified auditors.
• Prepare and / or review supplier audit reports, approve action plans (CAPA), and track their implementation until closure.
• Manage training needs within the department.
• Ensure timely delivery of documentation to clients related to activities under their responsibility.

Candidate profile:

• Fluent English and native Spanish proficiency.
• Detail-oriented with strong documentation and compliance mindset.
• Strong solution focus and ability to build and maintain relationships within the QA team and across business functions.
• Excellent business acumen with a deep understanding of organizational priorities and operational processes that drive profitable growth.
• Excellent attention to detail and ability to manage complex documentation.
• Strong problem-solving skills with the ability to initiate and implement improvements.
• High resilience and ability to adapt to a dynamic work environment.
• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related field.
• Minimum 2 years of experience in Quality Assurance, GMP Compliance, or Quality Operations in the pharmaceutical or API manufacturing industry.
• Strong understanding of GMP compliance (EU / FDA), ICH Q7 guidelines, and Data Integrity (ALCOA+ principles).

If you are looking for an opportunity to contribute to a leading API manufacturer and be part of a collaborative and innovative team, we would love to hear from you! Apply now and join UQUIFA Group in shaping the future of pharmaceutical manufacturing.