Quality Assurance Specialist

3 weeks ago


Singapur, Singapore Amaris Consulting Full time
Job Summary

Amaris Consulting seeks a skilled Quality Assurance Specialist to oversee Quality compliance in validation processes, with an emphasis on Data Integrity.

  • Collaborate with Subject Matter Experts to conduct gap analyses and risk evaluations prior to qualification efforts.
  • Participate in investigations of validation discrepancies, aiding in the review and approval of discrepancy reports and ensuring CAPA closures.
  • Review and authorize various validation documentation, such as protocols and reports.
  • Provide assistance and solutions for validation-related inquiries and challenges.
  • Evaluate and approve routine SOPs, forms, and other relevant documents, including Manufacturing Batch Records.

Requirements

  • Background in Quality Assurance or Quality Control within a regulated setting.
  • Familiarity with validation processes and principles of Data Integrity.
  • Strong analytical and problem-solving capabilities.
  • Excellent communication and collaborative skills.


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