Reviewer Profile

Shambhu Sarkar

Jubilant HollisterStier LLC
Sr Manager - Pharma Serialization / IT

Speciality

Global medicine serialization, EPCIS, Traceability, Computer System Validation - 21CFR Part 11, GMP, cGMP, GAMP Compliance, CMO/MAH Integration for medicine serialization and traceability, Packaging integration with serialization system and tempar-proof packaging, SAP Implementation for Global production support, RFID Barcode integration with EPCIS and SAP, EDI/IDocs, TrackwWise, ComplianceWire, SAP S/4 HANA Sales, EWM


Education

Master of Commerce: Shobhit University

Micro-master’s in healthcare Administration – Doane University, US                                             

Bachelor of Commerce: Delhi University

Certified Project Management Professional – PMP

Certificate in SAP S4 Hana

Certified SAFe Agilist

Certificate in Healthcare Information and Technology in decision making: Doane University, US

Certificate in Healthcare Finance, Economics and Risk: Doane University, US

Certificate in Strategic Leadership in Healthcare: Doane University, US

Certificate in Healthcare Organization and Delivery model: Doane University, US

Certificate in Healthcare Law, Policy and Advocacy: Doane University, US   

Certificate in Organization Culture and Change in Healthcare: Doane University, US

Certificate in Vulnerable Population: Doane University, US                                  

GS1 Certificate in Traceability Intermediate

GS1 Certificate in Traceability Basics

GS1 Certificate in ID Keys – Intermediate GRAI, GIAI

GS1 Certificate in ID Keys – Basic GTIN, GLN, SSCC

GS1 Certificate in Basic intro GPC

GS1 Certificate in eCOM-Basics

GS1 Certificate in Barcode Basics – EAN UPC

GS1 Certificate in Intermediate AI’s, Datamatrix, GS1-128

Certificate in Computer System Validation (CSV): IGMPI

Managing Successful Programs (MSP): AXELON, UK

PRINCE2 (Project Management): UK

Certification in ITIL, V3,

SIX SIGMA – IIT Delhi


Experience In

Organized professional with 18 years of experience and proven success in large scale SAP implementations and Global Serialization projects. Successfully implemented DSCSA and EU-FMD, serialization compliance. Actively implementing upcoming Various global serializations regulations, integrating Distributors/Wholesalers for DSCSA-2023 compliance.