Sandeep Chakraborti

• Motivated product owner/service manager and validation lead having 8+ years of experience in Information technology industry serving FDA regulated Biotechnology and Pharmaceutical clients.
• Extensive experience in writing and reviewing documentation for Computer System Validation Life Cycle, Validation Master Plan, Risk Assessment strategy, Test Plan document, Test Protocol, Test Scripts, Installation Qualification (IQ)/System Testing, Operational Qualification, Performance Qualification, Validation Summary Report and Test Materials/user guides and SOP's.
• Reviewing Corporate Quality Guidelines and Corporate Quality Standard Operating procedures identifying possible gaps, applicable industry practices not being implemented, and other industry standards.
• Hands-on experience in Implementation, enhancements and upgrades along with end to end business knowledge to provide technical solutions for different high GxP Laboratory systems and building lasting customer relationships.

• Thermo Scientific Sample Manager LIMS and Chromeleon
• BIOVIA LES, LIMS and Pipeline Pilot
• Waters CDS Empower
• Agilent OpenLab
• Trackwise
• Application Lifecycle Management

• Agile SAFe 5 Practitioner
• ITIL V4
• Six Sigma Green Belt

Citizenship : India

Canada Visa Status : Permanent Resident

US Visa Status. : B1/B2

• English
• Hindi
• Bengali
• Telugu

• End to end implementation of BIOVIA LES, LIMS, PipelinePilot, CDS Empower and Chromeleon applications to move them behind firewall to secure Quality Control Lab Systems against any Cyber Attacks.
• Successful version upgrades and migrations for various Quality and Process Development systems.
• Led multiple validation teams to achieve end goal by adhering to GxP processes during system validations.