
Niraj Patel
An accomplished Analytical Chemist with more than 2 years of experience in generic pharmaceutical R&D and QC lab,... | Apex, North Carolina, United States
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Niraj Patel’s Location Apex, North Carolina, United States
Niraj Patel’s Expertise An accomplished Analytical Chemist with more than 2 years of experience in generic pharmaceutical R&D and QC lab, focusing on Analytical services which include but not limited to Method development, Method Validation, method transfer and analysis of Raw materials, API's, In process, Finished product and Stability samples. • Experienced in Method development, Method Validation and Method transfer of new analytical methods. • Preparation of Method validation and verification protocols and reports. • In depth working knowledge of cGMP, GLP, ICH guidelines and FDA regulatory requirements for testing and validation procedures. • Performed Qualitative and Quantitative tests which included analysis of Raw materials, API's, In process (IP), Finished product (FP) and Stability (ST) samples. • Trained for handling and testing of controlled substances. • Performed Vender qualification for Raw materials. • Conducted Stability studies of drug products, Maintained stability chambers and stability chart records, prepared stability protocols, Maintained accurate records of stability samples, wrote and reviewed stability reports and performed trend analysis based on the stability data. • Hands on experience in operational knowledge of analytical instrumentation like HPLC (UV, RI, PDA detectors), GC, LC/MS, UPLC, TLC, Dissolution apparatus, FTIR, UV-VIS spectrophotometer, Karl Fisher, polarimeter and wet chemistry techniques. • Performed maintenance and Calibration of Analytical Instruments such as HPLC, UPLC, UV, FT-IR, Dissolution apparatus, pH meter and analytical balances. • Experienced in generating results by using Empower software for calculation. • Familiar with writing SOP’s, Analytical test procedure, Specification, and COA's. - Preparation and Investigation of Out-Of-Specification (OOS) results.
Niraj Patel’s Current Industry Catalent Pharma Solutions
Niraj
Patel’s Prior Industry
Catalent Pharma Solutions
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Work Experience

Catalent Pharma Solutions
Associate Scientist
Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Present