Sr Quality Assurance Analyst

2 semanas atrás


Rio de Janeiro, Brasil Guerbet Tempo inteiro

Join to apply for the Sr Quality Assurance Analyst role at Guerbet

At Guerbet, we build lasting relationships to enable people to live better. This is our purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for over 100 years, we continuously innovate to improve diagnosis, prognosis and quality of life for patients.

Our values are Customer centricity, Cooperation, Audacity, Focus, and Responsibility, which we practice daily. Working at Guerbet means being part of a multicultural team with nearly 3,000 people across more than 20 countries and playing a unique role in the future of medical imaging.

YOUR ROLE
  • Operationalize activities related to Guerbet's Quality System, according to applicable Good Practice guidelines, to the SACP (Corrective/Preventive Actions), Supplier Qualification, Audits, Supplier Deviations, Risk Management and Quality Gembas processes.
  • Know, comply with, and respect HSE (Safety, Health, and Environment) procedures, instructions, and rules as part of daily responsibilities; act to ensure personal safety and contribute to the safety of others; adopt safe behavior.
  • Participate in safety, health, and environment training and initiatives; maintain risk awareness in daily work.
  • Keep systems and databases updated regarding the status of each process.
  • Train internal customers on Quality System procedures.
  • Incorporate Global Policies and Guidelines into internal procedures via Electronic Document Management (EDM).
  • Prepare gap analyses of procedures, policies, and legislation related to activities within the Quality System.
  • Develop/review schedules for compliance with the Quality Audit plan; prepare Quality Audit Reports; critique and monitor audit action plans.
  • Provide support for Health Agency Inspections (Brazil and France); participate in the organization to receive Corporate Audits/Inspections.
  • Develop Technical Rationales to define the frequency and criticality of Suppliers/Service Providers; prepare and present at monthly SACP meetings.
  • Present on EHS topics at least once a month at the DDS meeting; participate in and monitor actions of Quality Management Groups (GEMBAS).
  • Support in preparing the QMR (Quality Management Review) presentation; update data related to activities in the Weekly Report.
  • Submit samples related to the Supplier Deviation process; develop KPIs related to activities.
ADDITIONAL DUTIES
  • Deviation related to Distribution & Transportation
  • DocuSign Administrator
  • Electronic Document Manager (EDM) support
  • Collection/Collection Simulation
  • GMP training; Supplier Deviation related to Distribution & Transportation
YOUR BACKGROUND
  • 4 years of Quality Assurance experience
  • Undergraduate degree
  • Knowledge of Brazilian Good Practice regulations relevant to the pharmaceutical sector
  • Microsoft Office, software skills
  • Advanced English
  • Data processing and presentation skills
  • Good communication skills
  • Attention to detail
  • Organization and critical thinking
  • Must be proactive and a team player
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Medical Imaging / Pharmaceutical
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