Quality Assurance Specialist

4 weeks ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Summary

Recruit Express Pte Ltd seeks a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the accuracy and compliance of our pharmaceutical products. Your primary responsibilities will include reviewing and approving master batch records, cleaning records, and GMP documentation, as well as ensuring adherence to quality procedures and regulatory requirements.

Key Responsibilities

  • Review and approve master batch records and subsequent batch records
  • Review and approve cleaning records and procedures and ensure compliance with set
  • Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
  • Review and approve deviations according to the site procedures
  • Handle product complaints.
  • Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
  • Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
  • Conduct internal and external audits
  • Maintain inspection readiness and support inspections from regulatory agencies and customers.
  • Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
  • Support the maintenance of validated stated of GMP systems and processes.
  • Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner


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