Drug Substance Release Specialist

13 hours ago


Singapore beBeeCompliance Full time $80,000 - $120,000
Quality Assurance Expert

This role is accountable for establishing and ensuring the testing of drug substance release and stability, including all testing of intermediates in process. The individual must control samples and lab operations according to written testing SOPs and local/international regulations.

Key Responsibilities:
  • Handle out-of-specification (OOS) events.
  • Define and implement Corrective Action Preventative Actions (CAPA).
  • Trend Key Performance Indicators (KPIs).

The successful candidate will ensure all activities are compliant with current Good Manufacturing Practices (cGxP), including data integrity review and approval of analytical data/tests (analytical release). They will also be responsible for:

  • Stability testing, including protocol preparation, evaluation, and report writing.
  • Reporting, including trend analysis and evaluation.
  • Performance of Stability studies, protocols, and comparative reports for supplier qualification.
  • Review and approval of analytical tests (analytical release).
  • Microbiological Quality Control, including testing of materials and utilities, environmental, and personnel monitoring.
  • Providing expert support for site qualification and validation activities.
  • Maintaining and calibrating equipment, including plan preparation.
  • Supporting supplier qualification.
  • Trending and analysis of KPI/KQI.
  • Supporting sample planning and sampling execution.
  • Reporting technical complaints/adverse events/special case scenarios related to products within 24 hours of receipt.


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