Job Description Summary
Familiarity with Good Laboratory Practices (GLP) and cGMP standard and understanding of FDA regulations, especially 21 CFR Part 211 for pharmaceutical QC labs
.Independently conduct tests
• Analyze data and generate reports
• Handle complex tasks and projects
• Ability to handle out-of-specification (OOS) investigations, data integrity, and documentation practices.
Job Description
Required Analytical Experience:
- Analyst must having the Hands-on experience in analysis of Finished Products, Raw Materials, Stability Samples, and In-Process Samples (both wet chemistry and instrumental methods).
- Proficient in calibration and operation of QC instruments including:
- HPLC
- Dissolution Apparatus
- FT-IR
- UV-Visible Spectrophotometer
- Karl Fischer Titrator
- Friability Tester
- Disintegration Tester
- Ensures laboratory compliance with Good Laboratory Practices (GLP).
Instrument Handling Expertise:
- HPLC (Waters)
- GC (Agilent)
- UV/Vis Spectrophotometer
- Dissolution Apparatus
- Karl Fischer Titrator
- FT-IR Spectrometer
- Particle Size Analyzer
- Differential Scanning Calorimeter (DSC) & Thermogravimetric Analyzer (TGA)
- Analytical Balance
- pH Meter & Conductivity Meter
- Disintegration Test Apparatus
- Friability Test Apparatus
Required Analytical Experience:
- Analyst must having the Hands-on experience in analysis of Finished Products, Raw Materials, Stability Samples, and In-Process Samples (both wet chemistry and instrumental methods).
- Proficient in calibration and operation of QC instruments including:
- HPLC
- Dissolution Apparatus
- FT-IR
- UV-Visible Spectrophotometer
- Karl Fischer Titrator
- Friability Tester
- Disintegration Tester
- Ensures laboratory compliance with Good Laboratory Practices (GLP).
Instrument Handling Expertise:
- HPLC (Waters)
- GC (Agilent)
- UV/Vis Spectrophotometer
- Dissolution Apparatus
- Karl Fischer Titrator
- FT-IR Spectrometer
- Particle Size Analyzer
- Differential Scanning Calorimeter (DSC) & Thermogravimetric Analyzer (TGA)
- Analytical Balance
- pH Meter & Conductivity Meter
- Disintegration Test Apparatus
- Friability Test Apparatus