Assistant Manager

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 In-process, 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. Toperformanalysis of stability samples as per stabilityschedule 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 inRM / Intermediates / APIs Ensure CFR 21 part -11 compliance and follow good 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.