Apprentice
Job Description
• To maintain and adherence of the GLP and safety procedures in laboratory.
• To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis.
• To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures.
• To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard 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.
• 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 report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation.
• Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation 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 maintain reference / working standard/impurity standard usage records.
• To maintain instrument history record.
• Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC.
• Preparation of stability protocols and stability reports.
• To perform analysis of stability samples as per stability schedule
• Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
• Perform holding time study of intermediates and preparation of reports.
• Inform and Investigate OOS results in RM/Intermediates/APIs
• Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to
• Maintain proper data integrity.
• To ensure no spillage of lab. Chemicals / solvents
• To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents.
• To coordinate with store department to prior information of urgent analysis of raw material.