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QA/RA Executive

Salary undisclosed

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Regulatory Affairs and Quality Assurance Executive

As a Regulatory Affairs and Quality Assurance Executive, based in Jakarta, you will support the QARA Manager in ensuring compliance with regulatory requirements and quality standards for the company’s medical devices. This role focuses on the operational aspects of both regulatory affairs and quality assurance, contributing to the efficient approval, registration, and ongoing compliance of products.

Responsibilities:

  1. Uploading/managing e-catalog for medical device.
  2. Reviewing medical device registration document.
  3. Implementing and running ISO 9001 Quality Management System.
  4. Serving as a dual-role professional, responsible for both Regulatory Affairs and Quality Assurance functions.
  5. Practicing Good Documentation Practice.
  6. Preparing regular report (e-report) to MoH.

Requirements:

  1. Diploma Degree of Pharmacy, Bachelor Degree of Pharmacy, Biomedical Engineering.
  2. Certified pharmacist is preferred.
  3. Minimum 1 year of experience in pharmaceutical or medical device industry (principal/distributor).