Primary Responsibilities:

 Analytical Method development for API/NCE sample.  Analysis of raw material, Intermediate, API/NCE samples on gas chromatography, liquid chromatography and chemical analysis.  Method validation for API/NCE purity, impurity, excipients methods.  Trouble shooting of various analytical issues for various products.  Maintenance, calibration & trouble shooting of HPLC and GC.  Preparation of SOP for related to instrument and system.  Method transfer and method demonstration at other location as and when required. Documentation like ATP, Development report, Validation protocol, Validation report, STP preparation. To work as per cGMP/OECD GLP and to ensure its compliance. Basic understanding of ICH guidelines Candidate should have basic knowledge about handling of instruments like UV visible spectrophotometer High-performance liquid chromatography Ultra-performance liquid chromatography Karl-Fischer Titration Differential scanning calorimetry USP Dissolution Apparatus I and II Other minor equipment like analytical balance, pH meter, Sonicator and microcentrifuge.