Senior Quality Assurance Specialist

1 semana atrás

Rio de Janeiro, Rio de Janeiro, Brasil Guerbet Tempo inteiro R$60.000 - R$120.000 por ano

WHAT WE ARE LOOKING FOR

This role will be responsible to 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. This person also must know, comply with, and respect HSE (Safety, Health, and Environment) procedures, instructions, and rules as part of your daily role and responsibilities, acting to ensure your own safety and contribute to the safety of others, always adopting safe behavior. They also must exercise their commitment to HSE through participation in safety, health, and environment training and initiatives, and continually exercise risk awareness in your daily work.

YOUR ROLE


• Keep systems and databases updated regarding the status of each process;


• Train users (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 their 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;


• Participate and present on EHS topics at least once a month at the DDS meeting;


• Participate in and monitor the actions of Quality Management Groups (GEMBAS);


• Support in preparing the QMR (Quality Management Review) presentation;


• Update data related to their activities in the Weekly Report;


• Submit samples related to the Supplier Deviation process;


• Develop KPIs related to their activities.

Additional duties the employee may be asked to perform, if necessary, provided they are trained to perform them:

  • 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 pharmaceutical sector
  • Microsoft Office, software skills
  • Advanced English
  • Data processing and presentation skills
  • Good communication skills
  • Attention to details
  • Organization and critical thinking a must
  • Must be proactive and a team player

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