QA Specialist

hace 1 semana

Panama Alcon A tiempo completo

Location: CDMX

As the global leader in eye care, Alcon has built a rich history of providing innovative products to customers and patients all over the world. We’re extremely proud of our legacy and the significant way we’ve helped to shape the industry over the last 70 years, but we’re just getting started. Our relentless passion to eliminate unmet medical needs drives our pursuit to further advance eye health worldwide. We’re looking for exceptionally talented, driven people who want to make a difference. If you’d like to help us change the way the world sees, this is your chance to Be Brilliant

How You Will Make a Difference

ESSENTIAL FUNCTIONS

Responsable de generar y mantener los procedimientos operativos estándar (SOPs) y los documentos necesarios para un SGC

efectivo y en cumplimiento de los requisitos regula-torios y estándares de Calidad aplicables.

Supervisar y asegurar que el operador logístico cumpla con los requisitos de Alcon

Garantizar el correcto almacenamiento, manejo, distribución y transporte de los produc-tos de acuerdo con sus

requerimientos.

Dar soporte en los elementos de calidad aplicables al clúster: inspección y liberación de producto, acondicionamiento, control

de cambio, manejo de no confomidades/CAPAs, quejas, retiro de producto, calificación de proveedores y entre otros.

Apoyar todas las investigaciones vinculadas a una desviación y/o queja de Distribución.

Brindar capacitación a los colaboradores sobre los procedimientos y procesos de GxP

Garantizar que los proveedores GxP estén debidamente calificados y monitoreados de acuerdo con los requisitos de calidad de

Alcon.

Llevar a cabo auditorías internas de calidad para demostrar el nível de cumplimiento de la unidad comercial y ayudar con

auditorías/inspecciones externas

Proporcionar apoyo para las inspecciones de Autoridad Sanitaria local.

Proporcionar informes mensuales a la gerencia sobre el progreso de las acciones correc-tivas y preventivas locales pendientes

Cualesquiera otras funciones o proyectos solicitados por el Gerente de Línea acorde con el grado y nível de responsabilidad

para este rol, para los cuales el asociado tiene la ex-periencia y/o capacitación necesaria

What We Can Offer You- Opportunity to join growing, early-stage organization built within a mature, stable global company- Friendly working environment and a diverse and highly motivated team- Individual career development plan and possible career growth within newly created account- Truly international environment and daily interactions with colleagues and stakeholders from all over the world- Attractive benefits & compensation package- Flexible hours and remote work possibilities (min 3 days per week office-based)

Skills For Success
- Key Requirements/Minimum Requirements_

Título Universitario o equivalente en disciplina científica o

ingeniería - requerido

Ingles Intermedio

KSAs Proficiency

Conocimiento de las normativas y guías para medicamentos y dispositivos

Familiaridad con ISO 13485 y GxP

Base de datos y experiência en informes (MS Office)

Habilidades interpersonales: Crea una buena relación y demuestra sensibilidad y conocimiento de otras personas y culturas.

Habilidades organizativas: Prioriza las tareas de manera eficiente y productiva, y administra bien el tiempo

Resolución de problemas: Adopta un enfoque lógico y analítico para resolver problemas; genera soluciones factibles y resuelve problemas/situaciones desafiantes

Auto-motivación: Emprendedor capaz de trabajar de forma independiente y proactiva por iniciativa propia

Centrado en el cliente: Asigna la máxima prioridad a la satisfacción del cliente; establece relaciones efectivas con los clientes, gana confianza y respeto; crea soluciones para las necesidades no satisfechas de los clientes

Orientado a los detalles: Preciso con un alto grado de orientación a los detalles

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