Especialista de Calidad

Description du poste:

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 de Calidad, serás responsable de garantizar el cumplimiento de los estándares de calidad y los requisitos regulatorios a través de la gestión de quejas de producto, investigaciones de calidad, desviaciones, CAPAs y procesos de liberación de producto.

Tu Rol //

* Gestionar investigaciones de quejas de producto provenientes del mercado.

* Liderar investigaciones de causa raíz y dar seguimiento a acciones correctivas y preventivas (CAPAs).

* Administrar desviaciones, no conformidades y controles de cambio.

* Revisar documentación de calidad para la disposición y liberación de productos.

* Participar en los procesos de liberación de lotes y producto terminado.

* Asegurar el cumplimiento de GMP, GDP y lineamientos regulatorios aplicables.

* Colaborar con áreas como Supply Chain, Regulatory Affairs, Manufactura y Calidad para la resolución de investigaciones.

* Mantener actualizados los registros y documentación dentro del Sistema de Gestión de Calidad (QMS).

* Participar en auditorías internas, externas e inspecciones regulatorias.

* Identificar tendencias, riesgos y oportunidades de mejora continua a partir del análisis de quejas, desviaciones y CAPAs.

Tu Perfil //

* Licenciatura en Química Farmacéutica Biológica (QFB), Farmacia o Química Farmacéutica.

* 3 a 5 años de experiencia en Aseguramiento de Calidad, Sistemas de Calidad o Cumplimiento Regulatorio dentro de la industria farmacéutica.

* Experiencia en gestión de quejas de producto, desviaciones, CAPAs, controles de cambio y liberación de producto.

* Conocimiento sólido de Buenas Prácticas de Manufactura (GMP) y Buenas Prácticas de Distribución (GDP).

* Conocimiento de la regulación sanitaria mexicana, incluyendo NOM-059-SSA1, NOM-073-SSA1, NOM-072-SSA1 y lineamientos aplicables de COFEPRIS.

* Conocimiento y manejo de la Farmacopea de los Estados Unidos Mexicanos (FEUM) y sus suplementos vigentes.

* Experiencia en Sistemas de Gestión de Calidad (QMS) y documentación regulada.

* Participación en auditorías internas, externas e inspecciones regulatorias.

* Inglés intermedio indispensable.

* Conocimiento de SAP y Veeva (deseable).

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!

Job Requisition ID: 301537

Location: Naucalpan de Juarez

Career Level: C - Professional (1-3 years)

Working time model: Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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