Quality Assurance Specialist

3 semanas atrás


Santo Amaro, Bahia, Brasil Healthcare Businesswomen's Association Tempo inteiro
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at the Healthcare Businesswomen's Association. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and safety of our services and products.

Main Responsibilities
  • Prepare and maintain AQMR and Site Master File documents to ensure compliance with regulatory requirements.
  • Support the implementation of analytical methods for Quality Control, ensuring accuracy and reliability of test results.
  • Implement global procedures locally, ensuring seamless integration with our global operations.
  • Support the 2nd independent check ArtWork approval flow with the QOP, ensuring quality and compliance.
  • Oversight GxP documentation, including management of controlled copies sent to third parties.
  • Develop and implement initiatives to promote quality culture within our organization.
  • Support the management and implementation of actions related to new regulations and resolutions.
  • Manage BSPO, RMV, and Bookkeeping, ensuring compliance with RDC 344/98.
Main Requirements
  • 1-3 years of experience in the pharmaceutical industry.
  • Intermediate English language skills, with ability to communicate effectively during meetings.
  • Focus on quality system and compliance.
  • Knowledge of risk assessment processes and GxP requirements.
  • Knowledge of local regulations.
Desired Skills
  • Continued learning and professional development.
  • Ability to deal with ambiguity and uncertainty.
  • Knowledge of GMP procedures and quality standards.
  • Experience in QA and Quality Control testing.
  • Self-awareness and ability to work independently.
  • Technological expertise and intelligence.

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