Prashant Warade

Quality Assurance Compliance Manager @Hikma Pharmaceuticals

Bedford, OH, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2024 — Present

Quality Assurance Compliance Manager @Hikma Pharmaceuticals

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Bedford, OH, US

EDUCATION

2012 — 2014

Sikkim Manipal Institute of Technology - SMU

Master of Business Administration (M.B.A.), Quality Management

N/A

IBSS College of Pharmacy, Malkapur

M Pharm (Quality Assurance), Master of pharmacy in Quality Assurance

SKILLS

ValidationPharmaceuticsQuality ManagementSterilizationRegulatory AffairsQmsDeviationsGmpCleaning ValidationCapaSopDeviation ManagementFdaGlp21 Cfr Part 11Technology TransferEquipment QualificationQuality AuditingAseptic ProcessingQuality SystemV&VChange ControlCgmpRegulatory SubmissionsSterile ValidationsRegulatory RequirementsFormulationQuality AssuranceDissolutionGeneric Programming

ABOUT PRASHANT WARADE

Quality Assurance Compliance Manager with over 20 years of experience in enhancing quality assurance operations and quality management systems. Proven track record in introducing and managing quality systems and processes, including the management of Quality for external suppliers and CMOs. Extensive experience in executing projects, including the qualification of new lines.A results-driven leader with a talent for guiding multicultural, multiskilled teams to achieve organizational goals and implement industry best practices. Successfully led compliance efforts that resolved an FDA consent decree, validating strategic approaches. Well-versed in cGMP, regulatory guidelines, and skilled in managing regulatory audits as a Certified Global Lead Auditor.

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