Executive
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 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.