Job Description
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
Required Analytical Experience:
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.
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
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