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Product Safety Expert

3 weeks ago

Shah Alam, Selangor, Malaysia Hiredly X Full time
About the Role:

This is an exciting opportunity to make a real difference in the field of medical product manufacturing. As a Quality Assurance Officer, you will play a vital role in ensuring that our products meet the highest standards of quality and safety.

Duties and Responsibilities
  • Work closely with Regulatory Affairs to implement and maintain the company's quality management system.
  • Take ownership of the company's ISO documentation system and ensure its accuracy and completeness.
  • Develop a deep understanding of manufacturing processes and conduct quality oversight.
  • Oversee the creation and maintenance of Device History Records (DHRs) and verify their accuracy and completeness.
  • Monitor and sustain the quality and integrity of all products manufactured at BIOVIC.
  • Review and sign off QA release forms for all commercial products.
  • Provide training on GMP and audits to employees as needed.
  • Coordinate and maintain the CAPA and NCR systems within the organization.