Trainee officer Quality Control

• Testing Raw Materials: Analyzing incoming active pharmaceutical ingredients (APIs) and excipients (inactive ingredients) to ensure they meet strict safety and purity standards before production begins.

• In-Process & Finished Product Testing: Checking the quality strength and identity of medications both during the manufacturing process and right before they are packaged for the public.

• Operating Analytical Equipment: Using advanced laboratory instruments like High-Performance Liquid Chromatography (HPLC) Gas Chromatography (GC) and UV-Vis spectrophotometers daily.

• Strict Documentation: Recording all test results calculations and observations precisely in laboratory notebooks or Electronic Lab Notebooks (ELN) to maintain a clear audit trail.

• Following Regulatory Guidelines: Executing all laboratory tasks in strict compliance with current Good Manufacturing Practices (cGMP) FDA guidelines and standard operating procedures (SOPs).

• Method Validation: Participating in the validation and transfer of analytical methods to ensure testing procedures are accurate reliable and reproducible.

• Handling OOS Investigations: Identifying reporting and investigating any Out-of-Specification (OOS) or unexpected test results to find the root cause of the deviation.

• Environmental Monitoring: Conducting microbial and chemical testing on the manufacturing environment including air quality and water systems to ensure zero contamination.

• Equipment Calibration: Performing routine calibration maintenance and troubleshooting of laboratory instruments to ensure they are functioning perfectly.

• Stability Testing: Testing retained product samples over extended periods under controlled temperature and humidity conditions to determine and verify a medicines shelf life.

Required Experience:

Unclear Seniority