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Bhaskar D Dhavle

Senior Associate

About Bhaskar D Dhavle


Bhaskar is an Associate - II at QualiCulture Consulting Group Consultants who has over 30 years of experience in the pharmaceutical industry. He has extensive experience in Quality Assurance and Quality Control functions, with a strong emphasis in commercial operations, compliance and regulations, site investigations, and root cause analysis. His experience includes pharmaceutical industries leading large-scale commercial operations. He is well versed with API, solid dosage and aseptic/sterile process technologies. Using his exemplary planning, negotiating, and project management skills, Mr. Bhaskar leads the development of quality management systems and organization of departments.
EXPERTISE:        

  • Direct Quality Assurance / Quality Control functions, including document control, release of testing results, and internal / external audits
  • Implement Quality Assurance programs which include ameliorate and remediate quality procedures to ensure sustainable compliance  
  • Lead development and implementation of commercial compliance policies, procedures, and controls
  • Develop and Monitor Key Quality Indicators and Metrics to assess the performance of Quality Systems 
  • Review manufacturing validation protocols and reports
  • Conduct root cause analyses and identify / implement corrective and preventive action plans
  • Manage site investigations for production (aseptic processing, compression, encapsulation and packaging)
  • Review batch records and disposition product for shipment
  • Guide Quality Risk Assessment and CAPA implementation
  • Provide scientific guidance to resolve issues related to FDA 483 observations and Warning Letters
  • Auditing of Vendors and Quality Control Laboratories
  • Acted as primary host for numerous regulatory inspections by US FDA, MHRA, TGA, ANVISA and MCC etc.
  • Design and Implementation of plans to ensure anytime inspection readiness 
  • Established manufacturing quality assurance procedures in alignment with prevailing regulations

EXPERIENCE:        

  • Head Quality Assurance at FDC LTD., Aurangabad      
  • Sr. Manage Quality Assurance at Emcure  Pharmacuticals Ltd.
  • Head Quality Assurance at Shreya Life Science
  • Analyst Quality Control at Wockhardt Ltd.

EDUCATION:      

  • Graduation in Chemistry


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