Tanmoy Kumar

Experience

• 

  Renata Limited

  Mar 2018 - Jun 2018

  Executive Officer, Stability (Quality Control)

  Major responsibilities were -• Ensure on time analytical testing of various stages stability products,• Ensure all routine scheduled work is completed on a daily basis and to report any required deviations to the schedule to the Shift In-charge,• Records all analytical test results in keeping with documentation standards,• Maintain records of retain, stability & samples as well as ensure that samples are properly stored,• Ensure the work place is kept safe, clean & tidy,• Daily function checking of various laboratory instrument,• Ensuring daily monitoring of stability chambers. Show less

• 

  Square Pharmaceuticals PLC

  Jul 2018 - now

  Major responsibilities were -• Plan and distribute analytical job to shift personnel and supervise the shift activities providing all types of technical support to complete the job within stipulated time.• Monitor and ensure shift activities in compliance with GXP and data integrity, assist junior colleagues to provide solution for analytical troubleshooting, calculation and data interpretation.• Handling of LIR, Deviation, CCR, QRM, FMEA, Risk Reduction Plan, OOT & OOS of products as per respective SOP.• Preparation of SOP, EOP, ECP, MOA and adhere to Pharmacopoeia’s regulatory, GLP, GMP guidelines.• Ensure analysis, documentation and reporting of waste water in ETP.• Train‐up & develop junior colleagues in operation of equipment’s, analytical job, safe handling lab reagents & other GLP issues.•Planning and coordinate analyst validation activities of laboratory personnel.• Justification, URS & CS preparation & Supervision of CDS system.• Maintaining yearly and monthly Preventive maintenance and Calibration schedule of all laboratory equipments.• Ensure Performance verification test for Dissolution Tester and Calibraion of laboratory equipments (HPLC, UV, Polarimeter, Refractometer, FTIR, Karl Fischer Titrator, Dissolution Media Preparator, Melting Point Apparatus) by self execution.• Ensure yearly laboratory calibration toolkits (Weight bar, Thermometer etc) calibration and yearly requirement against consumption of equipments various spare parts which is used in preventive or breakdown maintenance.• Manage & assure supplier arrangement for necessary maintenance of laboratory equipments or new equipment installation (IQ/OQ/PQ).• Inspect & investigate nonconformities, root cause analysis and determine corrective and preventive actions (CAPA) and ensure on-time and effective management of implementation of CAPA.• Conduct self-inspection Audit, vendor audit (RM & PM), and vendor rating for RM. Show less Major responsibilities were -• Routine analysis on bulk samples, semi-finished products and products in the quality control laboratory ensuring quality and timely generation of results.• Distributing analytical jobs among Analysts, Officers and Executives as laboratory Shift In-charge.• Review finished products, intermediates, raw materials and recovered materials upon approval of results by department management.• Handling of LIR, OOT & OOS of products as per respective SOP.• Preparation of SOP, EOP, ECP, MOA and adhere to Pharmacopoeia’s regulatory, GLP, GMP guidelines.• Ensure analysis, documentation and reporting of waste water in ETP.• Train‐up & develop junior colleagues in operation of equipment’s, analytical job, safe handling lab reagents & other GLP issues.•Planning and coordinate analyst validation activities of laboratory personnel.• Justification, URS & CS preparation & Supervision of CDS system.• Maintaining yearly and monthly Preventive maintenance and Calibration schedule of all laboratory equipments.• Ensure Performance verification test for Dissolution Tester and Calibraion of laboratory equipments (HPLC, UV, Polarimeter, Refractometer, FTIR, Karl Fischer Titrator, Dissolution Media Preparator, Melting Point Apparatus) by self execution.• Ensure yearly laboratory calibration toolkits (Weight bar, Thermometer etc) calibration and yearly requirement against consumption of equipments various spare parts which is used in preventive or breakdown maintenance.• Manage & assure supplier arrangement for necessary maintenance of laboratory equipments or new equipment installation (IQ/OQ/PQ).• Inspect & investigate nonconformities, root cause analysis and determine corrective and preventive actions (CAPA) and ensure on-time and effective management of implementation of CAPA.• Ensure management and overall improvement of laboratory to ensure satisfactory outcome in any regulatory audit. Show less Major responsibilities were -• Analysis of Raw Material, packaging Material, Bulk product, Finished Product & complaint sample.• Review of analytical report and disposition of product batch report to QA and raw material batch report to QC archive area.• Report all testing results and deviations encountered during testing along with problems related to instruments, methods etc.• Ensure accurate & proper documentation of analytical data and information.• Handling of LIR, OOT & OOS of products as per respective SOP.• Preparation of SOP, EOP, MOA and adhere to Pharmacopoeia’s regulatory, GLP, GMP guidelines.• Ensure analysis, documentation and reporting of waste water in ETP.• Ensure the initial and periodic training of QC Lab attendant/analysts/supervisor/reviewer.• Ensure Performance verification test for Dissolution Tester and Calibration of laboratory equipments (Polarimeter, FTIR, Karl Fischer Titrator, Dissolution Media Preparator, Melting Point Apparatus).• To execute Vendor audit for secondary packaging material.• Ensure GLP and safety equipment usage at the laboratory.• Ensure good housekeeping in the laboratory area.• Justification, URS & CS preparation & Supervision of CDS system. 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  • Sr. executive (M-13)

    Jan 2024 - now

  • Executive, Quality Control (M-14)

    Jan 2021 - Dec 2023

  • Executive, Quality Control (M-15)

    Jul 2018 - Dec 2020