Officer
Job Description
• 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.