Officer

Job Description

To maintain and adherence of the GLP and safety procedures in laboratory. To issuance of work data sheet / protocols from Q.A Department. To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. To perform wet analysis of In-process/ intermediate/ returned goods / Hold time , (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/ Spectrofluorometer / BD/TD, pH measurement to perform sampling of intermediate sample & swab sample from Production Department) 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 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 maintain instruments usage 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. Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. Perform holding time study of intermediates. To perform all the related Wet analysis and perform the online documentation for In-process, intermediate, returned goods Hold time 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. Inform and Investigate OOS results in Intermediates/APIs Ensure CFR 21 part -11 compliance and follow good Manufacturing practices during analysis, to maintain proper data integrity.

Keyskills :
Security Training