Akash S. Salunkhe

Senior General Manager (Quality Assurance & Regulatory Affairs) @Shamrock Pharmachemi Pvt. Ltd. - India

Mumbai, MH, IN

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Nov 2023 — Present

Senior General Manager (Quality Assurance & Regulatory Affairs) @Shamrock Pharmachemi Pvt. Ltd. - India

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Mumbai, IN

Shamrock Pharmachemi Pvt Ltd• Looking after Quality implementation & looking after Regulatory queries.• Leading the team for review of Data package for release of commercial batches. • Addressing queries of various clients for own manufacturing sites & third party manufacturing sites.• Addressing any technical queries of the manufacturing sites or any audit observations for own manufacturing sites or third party manufacturing sites.• Providing data or documents to regulatory agencies for registration of products.

EDUCATION

2001 — 2005

University of Mumbai

Doctor of Philosophy - PhD

2017 — 2019

Alliance University

Master of Business Administration - MBA

SKILLS

Method DevelopmentMethod TransferLicensing for R&DAudit of External Testing LaboratoryAudit of Api, Excipient and Packaging Material VendorVendor QualificationFormulation (Analytical Research and Development). Method Development EtcMethod ValidationLicensing for R&DResearch and Development (R&D)Vendor QualificationAudit of CROGood Laboratory Practice (Glp)Pharmaceutical IndustryCleaning ValidationFormulationAnalytical ChemistryGmpDissolutionPharmaceuticsV&VQms System Implementation in R&DFormulation (Analytical Research and Development)Formulation Adl (Anda Market),Method Development, Method Validn, Method TransferChemistryTechnology TransferData IntegrityAudit of External Testing Laboratory

ABOUT AKASH S. SALUNKHE

SUMMARY OF KNOWLEDGE AND SKILLS A goal oriented and experienced pharmaceutical R&D…

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