Quality Systems Lead LSP

hace 1 mes

Santiago, Chile 760 GlaxoSmithKline Chile Farmaceutica Limitada A tiempo completo

Quality Systems Lead LSP

Asegurar que se cumplan los requisitos obligatorios de GSK Quality Management Systems (QMS) en las LOC dentro del LSP Cluster (Chile, Ecuador y Peru). La función es fundamental para la gestión eficaz de sistemas y actividades que son cruciales o tienen un impacto directo en la calidad del producto y el cumplimiento normativo. Se espera que el rol tome la iniciativa en la implementación y el mantenimiento del QMS en LOCs dentro del LSP Cluster, proponiendo mejoras a los procesos, simplificación de los mismos, controlando y haciendo seguimiento para el cumplimiento e implementación efectiva del QMS.

Responsabilidades:

Responsable de toda la actividad y asuntos asociados a la implementación efectiva del QMS para LSP Cluster, mediante el seguimiento y revisión del estado de cumplimiento dentro de las LOCs de LSP. Soportar a QA Head LSP en establecer, registrar y gestionar de forma anual, el Quality Improvement Plan de LSP para implementar proactivamente la mejora continua. Llevar a cabo entrenamientos para brindar conocimientos sobre el QMS a las partes relevantes del negocio, permitiéndoles identificar, incorporar y cumplir con los objetivos de calidad relevantes e implementar las actividades del QMS que les aplican. Mantener un alto nivel de conocimiento del QMS y conciencia de los cambios dentro del entorno comercial para buscar oportunidades y gestionar posibles adversidades comerciales. Gestionar las reuniones de revisión de la gestión del Sistema de Gestión de Calidad de acuerdo con los procedimientos operativos estándar locales. Soporte al QA Head LSP en la coordinación y ejecución de los Quality Council de LSP. QMS implementation (process owner): process owner para estos procesos a nivel del clúster. Bajo este concepto, es el responsable de actualizar, implementar, entrenar y mantener los procedimientos de los procesos indicados, y cumplir las responsabilidades asignadas al rol de acuerdo a lo indicado en dichos procedimientos. Document and Data Management ​ (Process Owner)​: process owner para estos procesos a nivel del clúster. Bajo este concepto, es el responsable de actualizar, implementar, entrenar y mantener los procedimientos de los procesos indicados. Es responsable de la diseminación de los requerimientos de la política de GSK respecto a Data Integrity, tant a nivel interno como para los terceros de LOC Chile. VQD local administrator: responsable de la mantención y generación de tickets para nuevos accesos, adición de roles, eliminación de roles. Revisión periódica de perfiles y/o niveles de acceso otorgados dentro de LSP. Comunicación de curricula de entrenamiento a nuevos ingresos, entrenamiento básico de herramienta a nuevos ingresos. Resolución de problemas de manejo documental para LSP dentro de VQD. Desempeñarse también como Process Owner de los siguientes procesos a nivel Clúster: RCA y CAPA, Management Monitoring e Independent Business Monitoring, Organisation, Personal &Training and Quality Alerts and Bulletins. Desempañarse como Process Owner para la LOC Chile del proceso de Third Party Management.

¿Por qué TU?

Tus calificaciones:

Profesional Universitario con estudios en Químico Farmacéutico o de carreras afines. Conocimiento de aseguramiento de Calidad Experiencia en la industria farmacéutica mínimo 5 años en cargos similares Manejo de paquete office avanzado Manejo de Ingles avanzado Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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