Job Title Chemist HPLC Analysis Department Quality Sub Department Quality Control PURPOSE OF THE ROLE Responsible to perform HPLC analysis and document the same in compliance with cGMP, cGLP, EHS requirements and defined operating procedures. JOB DESCRIPTION (What the person needs to deliver at workplace) 1.Proper takeover of shift operations as per defined procedure as a reliever. 2.HPLC Systems & Analysis : Go through requisite procedures, plan and prioritize activities for the day based on work plan received from supervisor. Preparation of system suitability solutions, standard solutions and test solutions as defined in the procedures. Prepare mobile phase and start HPLC systems. Calibrate HPLC Equipment, evaluate system suitability and proceed for further analysis. As per the procedure process the chromatographs and submit the same for review. 100% adherence to cGMP and cGLP practices in line with 21 CFR Part 11. 100% adherence to EHS requirements as applicable to QC laboratory. Timely reporting of abnormalities/ Deviations to the immediate supervisor/ appropriate authorities. 3.HPLC Documentation : Record raw data pertaining to mobile phase preparation, system suitability solutions, standard solutions, test solutions, analytical and calibration results. Live recording of each activity, viz., instrument logbook, column usage log, working standard / reference standard / impurities reconciliation. Handover completed documents to reviewer / ongoing documents to reliever. 4.HPLC Maintenance Troubleshoot day to day issues with respect to instruments with the support of in- house service engineer. 5.Training Successful completion of assigned trainings and application of the same at workplace. QUALIFICATIONS/ EXPERIENCE REQUIREMENTS Parameter Minimum Preferred Education B.Sc. (Chemistry) M.Sc. (Chemistry) Experience (in Years) 2 4 Nature of Experience Hands-on experience on software and instruments (make n model). Awareness regarding quality systems, regulatory, cGMP and EHS requirements as applicable to pharmaceutical API Industry. COMPETENCY REQUIREMENTS # FUNCTIONAL Knowledge on Software and Instruments Quality Focus Troubleshooting BEHAVIOURAL Analytical Ability Attention to detail Proactive Problem Solving,
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Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Chemist - HPLC Analysis Job in Neuland