To maintain and adherence of the GLP and safety procedures in laboratory To perform the analysis as per work allocation and records the results in work sheet Protocols for raw material packing materials intermediates APIs Stability and etc as per current specification and method of analysis To work as Analyst and maintain the CFR 21 part 11 compliance by following laid down procedures To perform all the HPLC related analysis and perform the online documentation for Inprocess intermediate finished products returned goods raw materials Hold time Stability study working standard analysis as per laid down specification test procedures SOPs as per work allocation and report the analysis data in LIMS modules and report to Section Head Or QC head To ensure that every specification and method of analysis used of right product material code To follow the instruction of Shift Section In charge for analysis planning To report QI NQI OOS OOT Deviation discrepancy in laboratory analysis to QC In charge and initiate of QI NQI OOS OOT Deviation Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag To record and ensure all the entries and results are in line with current specifications and STPs To ensure the all column performance and column entry are maintain in column logbooks To maintain instruments log books properly as per analysis To acquire training from concerned person to update the cGMP system update technical knowledge To maintain reference working standard impurity standard usage records To maintain instrument history record Joint analysis with A R laboratory personnel during analytical method transfer on HPLC Preparation of stability protocols and stability reports To perform analysis of stability samples as per stability schedule Daily monitoring and recording of temperature and humidity of refrigerator working standard chamber and laboratory area Perform holding time study of intermediates and preparation of reports Inform and Investigate OOS results in RM Intermediates APIs Ensure CFR 21 part 11 compliance and follow valuable chromatography practices during analysis integration and reviewing of on line and off line chromatographic analysis to Maintain proper data integrity To ensure no spillage of lab Chemicals solvents To prepare mobile phase solution for analysis as per requirement to avoid wastage of lab chemicals and reagents solvents To coordinate with store department to prior information of urgent analysis of raw material