QC Specialist I

Job Description Summary

This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP's and local/international regulations.

Job Description

Key Responsibilities:  

• Sample storage and management.
• Analytical testing and documentation of API / drug substance / drug product / finished product / Complaints / stability / packaging material samples
• Ensure all activities in compliance with cGxP, incl. data integrity
• Stability (when not centralized)
  • Testing/Sample storage and management
  • Analytical documentation of stability samples to cGxP standards
• Detect and report potential accident, risks and propose solutions

Essential Requirements:

• Preferred: Previous experience working in a ...