Subinoy Palit

Experience

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  SHARIF PHARMACEUTICALS LIMITED

  Oct 2013 - Jul 2014

  Officer, Quality Assurance.

  • To undertake routine inspection activities in all areas of the Pharmaceutical Plant including Cephalosphorin production areas.• To undertake routine inspection in the Warehouse and check as necessary and achieve compliance of GMP activity.• To monitor changeover clearance in areas of activities and to analyze in process control samples and undertake changeover clearance as when necessary.• To undertake physical and chemical testing required for in-process control of products as required.• To verify calibration of all analytical balances.• To maintain vigilance in order to minimize dust and avoid cross contamination and monitor temperature and humidity in areas of activities.• To collect samples for retention of all batches of finished products manufactured for drugs authority. Show less

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  Square Pharmaceuticals Limited

  Aug 2014 - Apr 2021

  1. Analysis of Raw Material, Bulk product, Finished Product & complaint sample.2. Distributing analytical jobs among Analysts, Officers and Executives as lab in‐charge.3. Review of analytical report and disposition of product batch report to QA.4. Coordinate and monitor stock of laboratory reagents.5. Handling of LIR, OOT & OOS of products as per respective SOP.6. Prepare and update SOP and instrument related EOP.7. Ensure analysis, documentation and reporting of waste water in ETP.8. Coordinate analyst validation activities of laboratory personnel.9. Train‐up & develop junior colleagues in operation of equipment’s, safe handling lab reagents.10. Conduct training session as trainer.11. Ensure GLP and safety equipment usage at the laboratory.12. Ensure proper maintenance of QC equipment’s.13. Ensure good housekeeping in the laboratory area.14. Investigation of any incidences (QIR, QRM, OOS).15. Justification, URS & CS preparation & Supervision of CDS system. Show less  Analysis of Raw Material, Bulk product, Finished Product & complaint sample. Distributing analytical jobs among Analysts, Officers and Executives as lab in‐charge. Review of analytical report and disposition of product batch report to QA. Coordinate and monitor stock of laboratory reagents. Handling of LIR, OOT & OOS of products as per respective SOP. Prepare and update SOP and instrument related EOP. Ensure analysis, documentation and reporting of waste water in ETP. Coordinate analyst validation activities of laboratory personnel. Train‐up & develop junior colleagues in operation of equipment’s, safe handling lab reagents. Conduct training session as trainer. Ensure GLP and safety equipment usage at the laboratory. Ensure proper maintenance of QC equipment’s. Ensure good housekeeping in the laboratory area. Investigation of any incidences (QIR, QRM, OOS). Justification, URS & CS preparation & Supervision of CDS system. Show less

  • Sr. Executive, Quality Control, M-13 grade

    Jan 2019 - Apr 2021

  • Executive, Quality Control. M-14 Grade

    Jan 2017 - Dec 2018

  • Executive, Quality Control M-15 grade

    Aug 2014 - Dec 2016
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  Renata Limited

  May 2021 - Jul 2022

  Deputy Manager, Analytical Research and Development Department,USFDA Project

  1. A competent professional having about 8 years of experience in Analytical Method Development, Validation, Regulatory queryreply, Stability Evaluations and various routine analytical activities.2. To coordinate solid, Oncology and Injectable project related activities as a team leader for USA and other regulated market.3. To coordinate and execution of para filing (II, III and IV) and NCE-1 project.4. To organize reverse engineering for reference/market samples.5. To perform sophisticated instrumental analysis to aid of investigation and query reply.6. To accomplish drug excipients compatibility study, dissolution profiling, discrimination study, stability study, elemental impurities assessment, extractable and leachable study, method validation (Assay, RS, Dissolution, residual etc.), cleaning method development and validation, technical justification preparation, etc.7. A keen planner with expertise in maintaining streamlined functioning of laboratory and enhancing operational efficiencies.8. Instrumental in steering project management activities; ensuring sound quality analytical data and information compliance to regulatory requirements.9. To execute and ensure the preparation of development protocol, analytical development report and report for method validation and query relevant activity. As well as maintain the good documentation practices.10. To help and support cross functional department (F R&D, RA, QA and QC).11. Train and technical coach to the subordinate for job training activity.12. To implement and ensure the GLP and cGMP activity.13. Being involved investigation of incidence, deviation, justification etc. for failure during practical activity.14. Having effective written and oral communication; and presentationwith problem solving & troubleshooting skills. Show less

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  Healthcare Pharmaceuticals Limited

  Aug 2022 - now

  Assistant Manager, Analytical Research and Development at Healthcare Life Science Limited

  1. In-charge, Analytical Research and Development ( AR&D). 2. Work experience on Analytical Method Development and Validation (Dissolution, Assay, Related Substance, Residual solvent, Elemental impurities) for Drug substance (API) and Drug product (solid dosage form, liquid, injection).3. Review analytical method validation and tech transfer protocol and report.4. Executing the tech transfer activities. (R&D to QC)5. Instrumental operational skills on laboratory instrument and maintenance such as UV-Viss, FTIR, HPLC, GC, ASS, PXRD, ICP-MS, Malvern particle size Analyzer, Viscometer, Karl fishertitrator, Potentiometric titrator, Tap Density Tester, Refractometer, Dissolution Tester, Disintegration tester, Hardness tester, Melting point apparatus.6. Work experience on analytical and Instrumental trouble shooting, root cause investigation and prepare action plan7. Work experience on USFDA, MHRA, WHO , TGA and MCC regulated market.8. Executing and planning manpower development activities.9. Executing quarries reply, DMF review, CRO and vendor communication, .10. Implement GMP, cGMP, GDP, GLP.11. Executing stability plan for new formulation and self life determination as per ICH requirements Show less