QC Analyst

Key Responsibilities

Operational

• Perform testing of incoming raw material samples (e.g., FTIR, identity by wet chemistry, reagent preparation, sample receiving).
  
  
• Manage and store raw material samples in compliance with cGMP.
  
  
• Perform analytical testing and documentation for raw materials, API, drug substances/products, packaging materials, complaints, and stability samples.
  
  
• Conduct stability testing, sample storage, and documentation (if not centralized).
  
  
• Maintain QC Raw Materials laboratory in full cGMP compliance.
  
  
• Execute method validation/verification and routine release testing for raw materials.
  
  
• Perform data entry and review of RM packages for batch release.
  
  
• Support laboratory improvement projects, investigations (OOS, deviations), and change controls.
  
  
• Prepare for and participate in internal audits and health authority inspections.
  
  
• Undertake other duties or projects as assigned by the Section Manager.
  
  

HSE

• Comply with all HSE policies and guidelines.
  
  
• Identify, report, and propose solutions for potential hazards and risks.
  
  
• Actively participate in initial and ongoing safety training.