Kajol Shah
Qa @Deciphera Pharmaceuticals
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WORK HISTORY
Qa @Deciphera Pharmaceuticals
EDUCATION
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master's Degree, MBA Pharma Tech
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Bachelor's degree, Pharmacy
Northeastern University
Master of Science - MS, Regulatory Affairs and Project Management
ABOUT KAJOL SHAH
Knowledge and Skills In-depth knowledge of FDA guidelines, ANDAs, DMF, IND, NDA, BLA, 510(K), PMA, De-Novo Possess a strong, detailed knowledge of site’s manufacturing processes and procedures, cGMP, risk assessment, gap analysis, 7 QC tools, t-test, ANOVAs, capability analysis Proficient in Microsoft Office, MS Project, SharePoint, Minitab, Adobe Acrobat, Visio, SAP, Sparta TrackWise Interpersonal: Verbal and written communication, organizational, self-motivated, multi-tasking, detail oriented
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