External Supply Quality Specialist

hace 6 días

Bogotá, Bogotá D.E., Colombia Merck Healthcare A tiempo completo

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Como Especialista en Garantia de Calidad, serás responsable de supervisar sistemas de calidad y gestión de riesgos para garantizar el cumplimiento normativo en operaciones de fabricación por contrato (CMOs). Tu enfoque estará en asegurar la conformidad con estándares internacionales (ISO, GxP, GMP, GDP) y regulaciones locales (INVIMA, COFEPRIS, DIGEMID, entre otras), liderando iniciativas de mejora continua y mitigación de riesgos.

Tu Rol

  • Supervisar sistemas de calidad y riesgos (controle de cambios, desviaciones, CAPAs, gestión de riesgos).
  • Gestionar documentación, instrucciones de fabricación y embalaje, métodos analíticos, validaciones de procesos y métodos analíticos, VCP, PQRs y acuerdos de calidad.
  • Asegurar cumplimiento regulatorio y buenas prácticas de fabricación en operaciones con CMOs.
  • Supervisar las auditorías de los proveedores, evaluaciones de riesgo y mejora continua.
  • Colaborar con equipos multifuncionales (QAs de las Subsidiarias, Supply chain, Regulatory Affairs, Global External manufacturing functions).
  • Presentar métricas de calidad a la alta dirección.

Tu Perfil

  • Formación en Farmacia, Química o afín.
  • +8 años de experiencia en calidad farmacéutica, idealmente con CMOs.
  • Conocimiento de normativas internacionales y locales (INVIMA, COFEPRIS, DIGEMID).
  • Manejo de sistemas como TrackWise, Veeva.
  • Inglés fluido (indispensable) / Portugués (deseable).
  • Enfoque analítico, colaborativo y orientado a resultados.
  • Conocimientos de herramientas de tecnología de la información (Microsoft Office, Power BI)
  • Buenas habilidades comunicativas e interpersonales.

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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