• 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 and humidity of refrigerator / cooling cabinet working standard chamber and laboratory area. • Ensure CFR 21 part-11 compliance and follow the SOP/STP for analysis to maintain proper data integrity. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. • To ensure awareness about the MSDS for 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 laboratory chemicals and test samples at proper place with segregation to prevent accidents/contamination. • To ensure no spillage of lab. Chemicals / solvents • To draw required sample quantity only for analysis of material to avoid wastage of material. • To prepare required solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents. • To co – ordinate with cross function department for cGLP systems and its maintenance, up-dation. • To co – ordinate with production department for on line analysis support requirement, planning/clubbing of analysis. • To co – ordinate with EHS for safety and environment related activities and its management. • Give necessary and transparent feedback to the supervisors for continuing the production activities effectively. • Inform/ discuss with Section head of any breakdowns, deviations, quality issues etc. • Prepare and submit reports as required. • To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.
