Air Liquide

Industrial and medical gas provider

Farmaceuticos - Coordinador de Calidad y Asuntos Regulatorios

Regulatory & Quality (Life Sciences)Updated on Nov 12

Full-timeRosario, Santa Fe Province, ArgentinaNo salary listedIn-person

About the Job

Requirements

A university degree in Pharmacy (Pharmacist) is required, with the degree available to be registered with the regulatory control authorities of Santa Fe Province.
Basic English proficiency is valued.
Knowledge of good manufacturing practices is valued.
Computer skills are valued.

Responsibilities

Ensure that all medicinal gases produced or packaged in Rosario comply with applicable legislation from ANMAT and Santa Fe Province, and ensure that safety, quality, and environmental rules and laws are applied at the facility.
Support and ensure analytical testing of medicinal products.
Manage the release of medicinal specialties as the authorized Technical Director before ANMAT and the Ministry of Health of Santa Fe Province.
Support quality assurance for products at the Rosario plant in accordance with Ministry of Health Resolution 1130/2000.
Complete, check, and archive records required by internal procedures and current legislation concerning medicinal products.
Identify, assess, and/or promote corrective and preventive actions and improvement opportunities using management-system tools to address safety, quality, and environmental deviations, including planning actions to correct deviations found in external and internal audits.
Support regulatory compliance for medicinal gases to maintain provincial and national authorizations with ANMAT.
Support compliance with the environmental plan for the Rosario branch.
Guide and coordinate collaborative handling of the facility’s medicinal-product complaints and non-conformity system.
Plan and coordinate calibration and maintenance of all measurement or analysis equipment in the medicinal laboratory.
Coordinate medicinal quality and regulatory matters for 12 filling plants together with JARyC.
Implement improvements in medicinal quality and regulatory matters for 12 filling plants together with JARyC.
Guide the review of national medicinal documents as IM Coordinator.
Support compliance with standards and legislation related to food safety.

How will you CONTRIBUTE and GROW?

Supervisar que todos los gases medicinales elaborados o envasados en Rosario cumplan con la legislación aplicable (ANMAT y provincia de Santa Fe) y controlar la aplicación de normas o leyes en materia de seguridad, calidad y medio ambiente a fin de garantizar su cumplimiento en el establecimiento.

Acompañar y asegurar la realización de los controles analíticos a los productos medicinales.
Gestionar la liberación de las especialidades medicinales como Director Técnico habilitado por ANMAT y Ministerio de Salud de Provincia de Santa Fe
Acompañar el aseguramiento de calidad según la Resolución Ministerio de Salud 1130/2000 de los productos de Planta Rosario.
Completar, controlar y archivar los registros exigidos por los procedimientos internos y la legislación vigente en materia de productos medicinales.
Identificar, relevar y/o promover acciones correctivas, preventivas y oportunidades de mejora aplicando las herramientas del sistema de gestión ante desvíos observados en materia de seguridad, calidad y medio ambiente. Esto incluye planificar acciones para corregir desvíos que surjan de auditorías externas e internas.
Acompañar el cumplimiento regulatorio de gases medicinales para mantener habilitaciones provinciales y nacionales (ANMAT).
Acompañar el cumplimiento del plan ambiental de la Sucursal Rosario.
Guiar y articular la atención colaborativa de los reclamos medicinales del establecimiento y el sistema de No Conformidades.
Planificar y coordinar las calibraciones/mantenimiento de todos los equipos de medición o análisis del laboratorio medicinal.
Coordinar la calidad y temas regulatorios medicinales de 12 plantas fraccionadoras junto con JARyC
Incorporar mejoras en calidad y temas regulatorios medicinales de 12 plantas fraccionadoras junto con JARyC
Guiar la revisión de documentos nacionales medicinales como Coordinadora de IM
Acompañar el cumplimiento de normas y legislación asociada a la inocuidad alimentaria.

___________________

Are you a MATCH?

Cualidades y competencias que te ayudarán a crecer

Educación formal: Título universitario en Farmacia (Farmacéutico/a) con título disponible para su bloqueo ante los entes regulatorios de control de la provincia de Santa Fe.
Conocimientos técnicos valorados: Manejo de PC, inglés (básico). Conocimientos en Buenas prácticas de manufactura.
Competencias clave para el rol: Compromiso con la calidad, la seguridad y el medio ambiente; Creatividad e innovación; Trabajo en equipo y comunicación fluida; Iniciativa en la adaptación al cambio; Orientación al cliente interno / externo; Autonomía con espíritu colaborativo e iniciativa; Análisis y resolución colaborativa de desafíos; Dominio y aplicación compartida de conocimientos; Relaciones interpersonales constructivas; Compromiso con el logro de objetivos compartidos.

Our Differences make our Performance

At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.

We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.

About the Company

Air Liquide

Industrial and medical gas provider

Air Liquide produces and supplies industrial and medical gases, such as oxygen, nitrogen, hydrogen, argon, and specialty gases, to manufacturers, healthcare providers, electronics, and energy companies. It operates through production plants, pipelines, cylinder networks, and on-site supply units, and it also designs and builds gas production and separation systems, including cryogenic air separation plants and large electrolyzers, via its engineering arm. Its Gas & Services business serves industry and healthcare and it is a major producer of hydrogen, investing in low-carbon hydrogen projects and electrolysis as part of industrial decarbonization. It serves the semiconductor industry and space programs as well. Its goal is to enable industrial decarbonization and the energy transition by providing reliable gases and engineering capabilities for large-scale gas production, hydrogen supply, and on-site services.

Company size: 10,001+
Company stage: IPO
Headquarters: Paris, France
Founded: 1902

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