Executive

Description

• 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. • 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 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.