Bhanudas Kadam

About Bhanudas Kadam

Pharmaceutical Quality Operation and Regulatory Compliance •…

Experience

1. Gm-quality and Compliance (Site Quality Head)

   Jenburkt Pharmaceuticals Limited

   Mar 2022 — Present · IN

   Responsible for Site Quality Operation,Third party Compliance,New vendor development,FDA Compliances Ensure the implementation of quality systems at site; Participate in Global QA activities; Auditing starting material manufacturers and traders, Lead qualification and validation activities, Participate in managerial hiring process, Oversee quality functions for manufacturing site; Ensure the implementation of quality systems at site; Auditing starting material manufacturers and traders, Lead qualification and validation activities, Participate in managerial hiring processSkills: CAPAs · Analytical Skills · Failure investigation · Good Manufacturing Practice (GMP) · GMP training · Deviation Management · Change Management · Vendor Management · Self-inspection · Internal Audits · Training & Development · Auditing · Quality Assurance,CMO\'s

Education

• Pune University

  Master of Science

Skills

• Hplc
• Csv Validation
• Andas
• Regulatory Affairs
• Capa
• Stability Study
• Quality System
• V&V
• Regulatory Filings
• Photostability Study
• 21 Cfr Part 210 and 211, Part 11 ,58 and 820 Cgxp( Gamp4 & Gamp5) Eu Annex-11
• Temperature Monitaring Study
• Cgmp Manufacturing
• Oos
• Method Transfer
• Internal Audit
• Quality Control
• Gmp
• Stability
• Corrective and Preventive Action (Capa)
• Finished Goods
• U.s. Food and Drug Administration (Fda)
• Calibration
• Dissolution
• In-Process
• Stability Programs
• Anda
• Change Control
• Raw Materials
• Cleaning Validation
• 21 Cfr Part 11
• Thermal Cycling
• Ndas
• Mhra
• Packaging Material
• Pharmaceutical Industry
• Sop
• Fda
• Glp
• Equipment Qualification