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Position: Global Quality Assurance SpecialistDesplácese hacia abajo para obtener una visión general completa de lo que requerirá este trabajo. ¿Es usted el candidato adecuado para esta oportunidad?Experience: 2-5 years in Quality Management Systems within pharmaceutical/biotech industryAt Insud Pharma, we operate across the entire pharmaceutical value chain, committed to innovation and sustainable development. Our Global Quality Management unit drives excellence worldwide, ensuring regulatory compliance and continuous improvement to safeguard human and animal health.Are you ready to be a #Challenger and make a real impact in the pharmaceutical industry? Support the implementation, maintenance, and continuous improvement of the global Quality Management System (QMS).Participate in defining and executing the global QMS strategy aligned with FDA, EMA, and other international regulations.CAPA, deviations, change control, audits, training, supplier management, and product release.Manage digital QMS tools (TrackWise, LIMS), ensuring compliance with 21 CFR Part 11 and EudraLex Annex 11.Monitor key performance indicators (KPIs) and prepare periodic reports to assess system effectiveness.Implement risk management principles across quality processes.Support the global audit program and supplier qualification.Promote a strong quality culture and continuous training throughout the organization.Collaborate with global teams to align quality processes and standards.Actively participate in digitalization and enhancement of quality management systems.2-5 years of progressive experience in Quality Management Systems within pharmaceutical, biotech, or medical device industries.~ Experience managing CAPA, deviations, change control, audits, and training.~ Proficiency with digital QMS platforms (TrackWise Digital, LIMS) and system validation.~ Fluent in English and Spanish.~ CSV training (GAMP 5) and familiarity with emerging technologies are a plus. xsgfvud Permanent contract#Professional development in a global, dynamic environment#Private health insurance#Continuous training and talent development programs#Opportunity to work on international projects with multicultural teams1 or 2 virtual or face-to-face interviews with HR and Hiring Manager.~
