• 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 the all activity related to working standard management. • To perform wet analysis of In-process/ intermediate/ finished product/ returned goods / raw materials/ Hold time / Stability study / working standard analysis (Test like Sulphated Ash/Residue on ignition/Specific Gravity/Water content by KF/Assay by manual or potentiometer titration, LOD/ Different type of limit test/ Melting or boiling point/ particle size analysis by air jet sieve/ analysis by UV spectrophotometer / BD/TD, pH measurement etc) as per work allocation and records the results in work sheet (Protocol) as per current specification and method of analysis and maintain the on line documentation. • If required 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 follow the instruction of Shift /Section In charge for analysis /planning. • To maintain instrument history record. • To report and raise any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to Section - In charge. • Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and up-dation of instrument calibration tag. • To record and ensure all the entries and results are in line with current specifications and STPs. • To maintain instruments log books properly as per analysis. • To acquire training from concerned person to update the cGMP system update technical knowledge.. • Preparation, qualification and management of working standard for Raw materials Intermediates/APIs . • To maintain reference / working standard/impurity standard usage records. • Daily monitoring and recording of temperature