Quality Assurance Senior Associate
hace 5 días
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
We believe that diversity is the driving force behind innovation, creativity, and overall business success.
Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today
Your Role: Responsable por la gestión de Aseguramiento de Calidad en la afiliada en cumplimiento con los Estándares Globales de Elanco y/o los procedimientos aplicables regionales y locales.
Soportar al área de farmacovigilancia en el reporte y seguimiento de las reclamaciones de calidad y/o eventos adversos que se reciben en la afiliada.
El rol de calidad contribuye a través del soporte continuo y el trabajo con el cliente interno a los procesos del negocio de la afiliada y la entrega de productos y servicios de calidada nuestros clientes.
Your Responsibilities: * Garantizar el cumplimiento de las Buenas Prácticas (GxP), incluidas las Buenas Prácticas de Almacenamiento, las Buenas Prácticas de Distribución y las Buenas Prácticas de Documentación, así como el cumplimiento de la normativa o regulación local.
* Gestión de Auditorías de Calidad internas y en conjunto con el área Regulatoria, gestionar las inspecciones externas por parte del Organismo Regulatorio local.
* Planificación y ejecución de autoinspecciones de calidad en la afiliada MAZ.
* Atender las auditorías realizadas por los clientes a la operación Elanco como parte de sus programas de certificación de sus sistemas de calidad.
* Ser el contacto principal en la Afiliada para cualquier problema relacionado con la calidad de los productos, incluida cualquier falla de calidad que deba escalarse a la Gerencia local y al Líder Regional de Calidad.
* Determinar con sentido de urgencia el impacto de posibles fallas de calidad en los productos, con especial atención a aquellas que puedan afectar la seguridad de clientes, usuarios y animales u originar un Recall (retiro del mercado).
* Gestionar las desviaciones ocurridas en la afiliada y terceros contratados por la Afiliada, incluyendo los correspondientes planes de acción correctivos y preventivos.
* Garantizar la inspección física local de los productos terminados entrantes como requisito para la liberación de los productos en el sistema.
Asegurar la capacitación requerida al personal del Almacén que apoya estas inspecciones.
* Disposición de lotes de producto terminado para su distribución al mercado.
* Apoyar a otros países de la región con actividades de calidad en ausencia del PQR correspondiente, de acuerdo al backup plan del área.
* Asegurar que los procesos de acondicionamiento o re-empaque local del producto, en caso de ser requerido, se realicen siguiendo los lineamientos establecidos por el área de Calidade acuerdo con los Estándares Globales de Calidad, procedimientos locales/regionales y normativa local en coordinación con el Área regulatoria.
What You Need to Succeed (minimum qualifications): * Título universitario en Farmacia, Química, Medicina Veterinaria, Ingeniería o otra especialidad; * Mínimo 5 años de experiencia en el área de aseguramiento de Calidad aplicado a la veterinaria y/o a la industria farmacéutica o otras industrias relacionadas.
* Inglés fluente; * Experiencia con procesos de Almacenamiento What will give you a competitive edge (preferred qualifications): * Habilidades de liderazgo para la gestión de peronas (reportes directos e indirectos) y liderar a través de la influencia (negiocios y terceros) * Buenas relaciones interpersonales.
* Habilidad para entrenar equipos.
* Capacidad de autogestion y establecer prioridades * Foco en el servicio al cliente, resoluciones de problemas y evaluación de diferentes alternativas Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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