Quality Assurance Manager LATAM

1 dia atrás

São Paulo, São Paulo, Brasil beBeeQuality Tempo inteiro R$80.000 - R$120.000
Job Opportunity:

We are seeking a seasoned professional to fill the role of Quality Assurance Specialist in our LATAM Regional office. This key position will play a vital part in expanding our company's Quality Management System, ensuring compliance with GxP systems and requirements.

Key Responsibilities:
  • Maintaining regional/local quality manuals, procedures based on CSL Vifor processes
  • Setting contractual obligations for quality with service providers
  • Managing product complaints, issues, deviations, CAPA, and recalls
  • Ensuring training of regional offices and local affiliates on the QMS using Learning Management software (LMS)
  • Maintaining LMS systems, updating, and conducting annual reviews
  • Preparing inspection readiness programs and supporting health authorities' inspections in the LATAM region
  • Managing deviations and incidents; conducting investigations at Distribution, Supply Chain, Warehouse, and global CSL manufacturing sites
  • Reviewing and approving compliance reports, following up on deviations related to these records
  • Defining corrective and preventive actions and monitoring their implementation
  • Change control management, documentation management, and complaint management
  • Following up on Product Quality Review reports with local manufacturers
  • Reviewing and approving transport deviation and product release with distributors
  • Conducting external and internal audits
  • Participating in setting quality objectives and continuous quality improvement projects
  • Ensuring the compliance of the quality management system with CSL global objectives
  • Providing GDP/GMP training to collaborators
  • Supporting continuous improvement and operational excellence initiatives
  • Implementing risk management principles
  • Experience in writing audit reports and temperature mapping reviews
  • Supporting partner qualification and negotiating quality agreements
Requirements:
  • A degree in health, life sciences, medical science, or engineering; or equivalent experience
  • 3-5 years of pharmaceutical industry experience
  • Knowledge of GxP systems & requirements; or understanding of GxP principles, concepts, practices, and standards
  • Understanding of risk management
  • Availability to travel 10% of the time
  • Excellent communication skills
  • Proficient in Good Documentation Practices
  • Excellent written and spoken English and Portuguese
  • Fluency in Spanish is considered a plus
  • Excellent computer skills: Word, PowerPoint, and Excel

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