Assistant Manager

• To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of work data sheet / protocols. • To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation. • To maintain the CFR 21 part -11 compliance by following laid down procedures. • To perform all the HPLC related analysis of In-process, finished products & returned goods / Hold time / Stability study /reference / 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. • To ensure that every specification and method of analysis used of right product/material code. • To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge. • 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 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.• Joint analysis with R&D personnel during analytical method transfer on HPLC. • 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. • Inform and Investigate OOS results in Finish /stability study. • Initiation of change control / deviations / NQI / QI/OOT related to QC.

Cadila Pharmaceuticals