QC Analyst (Raw Materials)

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.