• To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of work data sheet / protocols. • To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. • To perform all the GC related analysis of In-process, intermediate, finished products, Recovered solvents & returned goods / raw materials Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, and report the analysis data online and in LIMS modules and report to Section – Head. • To follow the instruction of Shift /Section In charge for analysis /planning. • Report any QI/NQI/OOS/OOT / 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 up-dation 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 record analytical data in work data sheets / protocols. • To maintain reference / working standard/impurity standard usage records. • To maintain instrument history record. • To perform joint analysis with AR Laboratory personnel during analytical method transfer on GC. • Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. • Inform and Investigate OOS results in RM/Intermediates/APIs. • Ensure CFR 21 part -11 compliance and follow good • Chromatography practices during analysis. • To ensure awareness about the MSDS to all concern persons. • To educate and train the workmen for safe handling of chemicals, gas, cylinder and laboratory instruments to prevent the accidents. • To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.
