Apprentice
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 Raw materials/ 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, IR, Polarimeter, Refractive Index 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 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 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.
• Inform and Investigate OOS results .
• Ensure CFR 21 part -11 compliance and follow good Laboratory practices during analysis.
• To performed Raw Material sampling activity, analysis activity.
• To performed Packing material sampling and analysis activity.