Sreebash Bhowmik

Experience

• 

  Incepta Pharmaceuticals Ltd.

  Apr 2014 - now

  1. Audit management as SME for UK-MHRA, Local HA and others.2. Writing different CAPAs.3. Review SOPs, testing methods, COAs and other analytical documents.4. Work on improvement in DI issues and compliance culture among the laboratory personnel.5. Prepare laboratory budget in a cost effective manner.6. Co-lead in laboratory transfer project.7. Perform Qualiy Risk Management, Investigations ( OOS,OOE, OOT,Change Management, Deviation and Market complain).8. Handling of Laboratory Incidents.9. Conduct training on different topics for laboratory personnel.10. Perform calibration of Dissolution apparatus.11. Act as 5s auditor.12. Supervise a team (13 person's).13. KPI evaluation of team members and overall laboratory KPI monitoring.14. Participate in decision making for all types of laboratory compliance issues. Show less 1. Implement and monitor Laboratory Data integrity.2. Perform Computer System Validation for QC instruments.3. Preparation of User Requirement Specifications for Laboratory instruments.4. Prepare Standard Operating Procedures.5. Act as SME in respective section of Quality Control compliance.6. Prepare Gantt chart for different laboratory activities and KPI.7. Skilled on ICH (Q9) Quality Risk Management.8. Completed train the trainer certification.9. Certified Hazardous Materials Management in Laboratory.10. Complete training on EI (As per USP) and perform validation accordingly.11. Solving problems of major laboratory equipment during routine operation.12. Co-lead in cephalosporin laboratory, Physical and Chemical Analysis Laboratory design as per Uk-MHRA and WHO. Show less 1. Perform all types of physical and chemical analysis of raw materials and finished products.2. Conduct daily calibration of Balance, pH meter, FTIR and KF.3. Operation of laboratory instruments including HPLC, AAS, GC,PSA,UV etc.4. Preparation of testing method & specifications to in line with current BP, USP, pH. Eur. and Supplier documents.5. Perform OOS investigation and Deviation.6. Work in working standard preparation and Reference standard management.7. Helps in raising requisition of laboratory items for smooth laboratory operation. Show less

  • Executive officer, Quality Control

    Jan 2022 - now

  • Senior Officer, Quality Control

    Jan 2018 - Dec 2021

  • Quality Control Officer

    Nov 2014 - Dec 2017

  • Management Trainee, Quality Control

    Apr 2014 - Oct 2014