Bhanudas Kadam

Gm-quality and Compliance (Site Quality Head) @Jenburkt Pharmaceuticals Limited

Mumbai, MH, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2022 — Present

Gm-quality and Compliance (Site Quality Head) @Jenburkt Pharmaceuticals Limited

View department →

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

N/A

Pune University

Master of Science

SKILLS

HplcCsv ValidationAndasRegulatory AffairsCapaStability StudyQuality SystemV&VRegulatory FilingsPhotostability Study21 Cfr Part 210 and 211, Part 11 ,58 and 820 Cgxp( Gamp4 & Gamp5) Eu Annex-11Temperature Monitaring StudyCgmp ManufacturingOosMethod TransferInternal AuditQuality ControlGmpStabilityCorrective and Preventive Action (Capa)Finished GoodsU.s. Food and Drug Administration (Fda)CalibrationDissolutionIn-ProcessStability ProgramsAndaChange ControlRaw MaterialsCleaning Validation21 Cfr Part 11Thermal CyclingNdasMhraPackaging MaterialPharmaceutical IndustrySopFdaGlpEquipment Qualification

ABOUT BHANUDAS KADAM

Pharmaceutical Quality Operation and Regulatory Compliance •…

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