Trainee

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

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