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Open nowPosted 63 days ago

QA MANAGER / QP

almirall53 open roles

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SANT ANDREU DE LA BARCA
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Your applicationOpen nowQA MANAGER / QPalmirall · SANT ANDREU DE LA BARCA
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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market. almirall postings stay open a median of 14 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 63 days ago

almirall median: 14 days open

The posting

We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.

Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

MISIÓN / RESUMEN DE LA POSICIÓN

Asegurar que las operaciones de fabricación y los Sistemas de Calidad de las plantas farmacéuticas cumplen con las cGMPs, los requisitos regulatorios aplicables y las políticas corporativas de Calidad de Almirall, garantizando la seguridad del paciente, la eficacia y la calidad de los productos farmacéuticos.

RESPONSABILIDADES

  • Asegurar el cumplimiento de las GMPs en las actividades de fabricación, acondicionamiento y control de calidad.
  • Revisar y aprobar la documentación operativa para la fabricación y control de productos farmacéuticos, incluyendo procedimientos, guías de fabricación y acondicionamiento, métodos analíticos, especificaciones, fichas de fabricación u otra documentación asociada.
  • Revisar la documentación generada durante los procesos de planta, verificando su correcta cumplimentación y adecuación a los requisitos establecidos.
  • Realizar auditorías internas periódicas para verificar el nivel de cumplimiento de las GMP y participar en auditorias de clientes e inspecciones regulatorias.
  • Evaluar el impacto sobre la calidad del producto y el cumplimiento GMP de los cambios propuestos.
  • Participar en la investigación y evaluación de desviaciones, incidencias de calidad, reclamaciones de mercado y otras no conformidades, garantizando análisis robustos y decisiones basadas en riesgos.
  • Realizar el seguimiento de las acciones correctivas y preventivas (CAPA), verificando su implementación y eficacia.
  • Revisar los registros que componen el Batch Manufacturing Record para garantizar su conformidad antes de la certificación y la liberación al mercado.
  • Apoyar las actividades de certificación y liberación de lotes de acuerdo con la normativa aplicable.
  • Promover el cumplimiento de normas de seguridad y medioambiente, identificando riesgos y proponiendo acciones de mejora.
  • Impulsar la mejora continua de la calidad según los principios de la ICH Q10 y a un enfoque de gestión basada en riesgos.
  • Fomentar una sólida cultura de calidad, integridad de datos, cumplimiento regulatorio y orientación al paciente en toda la organización.
  • Colaborar transversalmente con las distintas áreas operativas para promover la excelencia operacional y la toma de decisiones basada en calidad.

FORMACIÓN ACADÉMICA Y EXPERIENCIA REQUERIDA

  • Licenciatura o Grado en Farmacia. Se considerarán titulaciones universitarias en disciplinas científicas que cumplan los requisitos formativos establecidos para ejercer como Qualified Person (QP) según la normativa europea y española aplicable.
  • Conocimiento sólido en GMP’s.
  • Experiencia mínima de 1 año en QA, producción y/o control de calidad en ámbito químico-farmacéutico.
  • Nivel de inglés avanzado.

HABILIDADES Y COMPETENCIAS

  • Capacidad para revisión y aprobación de documentación técnica.
  • Sólida capacidad de toma de decisiones basada en riesgos.
  • Habilidades para la gestión de desviaciones, CAPAs, auditorías e inspecciones regulatorias.
  • Pensamiento analítico y capacidad para la resolución de problemas.
  • Orientación a la mejora continua y excelencia operacional.
  • Competencia para trabajar en entornos regulados, dinámicos y multiculturales.
  • Excelentes habilidades de comunicación, trabajo en equipo y gestión de stakeholders.
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