Summary
Overview
Work History
Education
Skills
Personal Details
Timeline
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Sujit D Chauhan

Sujit D Chauhan

Mumbai,Maharashtra

Summary

Experienced management professional with a proven track record of leading teams to success. Emphasis on collaboration, operational efficiency, and achieving measurable outcomes. Skilled in strategic planning, process improvement, and cultivating a culture of accountability and excellence. Recognized for adaptability and consistently meeting evolving organizational demands.

Overview

16
16
years of professional experience

Work History

Manager-CSV Risk Advisory

Ernst & Young LLP
04.2022 - Current
  • Well versed with life science domain and working as Senior consultant role in CSV profile.
  • Leading a team with monitoring and providing guidance in terms of compliance and competency in roll out of CSV activities.
  • Had an hands on SAP S4 HANA, S4 HANA with Rise validation.
  • Well versed with usage of HP -ALM, BOX, SOLMAN
  • Worked on AGILE, FOCUS methodology on S4, MES, MDG Usage & Maintenance.
  • Led cross-functional teams to enhance client service delivery and operational efficiency.
  • Mentored junior staff, fostering professional growth and improving team performance.
  • Conducted comprehensive project reviews, ensuring alignment with company objectives and compliance standards.
  • Accomplished multiple tasks within established timeframes.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Controlled costs to keep business operating within budget and increase profits.

Validation Project Lead

IVYWorks Advisors LLP
08.2019 - 03.2022
  • Acts as the onsite single point of contact for the Project.
  • Ensures effective co-ordination of resources and activities to meet the project objectives.
  • Ensures the appropriate allocation of IVY WORKS resources and timely execution of work in coordination with Client SPOC.
  • Conducts daily meetings with Client SPOC and provides daily status reports.
  • Conducts weekly onsite meetings with stakeholders.
  • Initiate, review, or approve modifications to project plans.
  • Documentation review, Quality controls over documentation, execution, compilation.
  • IT Infrastructure Implementation, Information Security, Change Management.
  • Automation systems (WinCC Foxboro), PLC/SCADA, Vision Systems Validation.
  • Knowledge of HP ALM Implementation/Monitoring/Usage.
  • QMS System, Risk Analysis Usage & Maintenance.

Sr.Officer-IT

Fresenius Kabi India Pvt Ltd
03.2018 - 08.2019
  • Initiate, review, or approve modifications to project plans.
  • Perform risk assessments to develop response strategies.
  • Monitor or track project milestones and deliverables.
  • Develop or update project plans for information technology projects including information such as project objectives, technologies, systems, information specifications, schedules, funding, and staffing.
  • Support to Quality Control, Quality Assurance and Manufacturing related instruments / Equipment's
  • Responsible for User Management, Admin control, Backup and Data security of all Workstations/Computers used in GxP environment.
  • IT Infrastructure implementation as per 21CFR PART11 &; Anex11, GAMP5 compliances in QC Lab and other Manufacturing area through cloud computing VM Esxi6.5 server implementation.
  • Review of Quality Management system documents (i.e. Change Controls, Deviations and CAPA etc.).
  • Trained users on the system implication and provided an independent oversight about an impact of 21 CFR Part 11 regulation
  • To coordinate with cross functional departments for procurement of new equipment, technical discussion and validation activity.
  • Executing, Reviewing and approving validation documents in accordance with company policies and procedures.
  • Execute/ Review Validation Plans, Test Plans, Test Summary Reports, Validation Summary Reports.
  • Well intended with use of Track Wise QMS system.
  • GAP analysis, Change control, GxP Assessment.
  • IT Infrastructure Management , Network Administration
  • Server Administration, Technical Support , Project Management
  • Symantec Endpoint security, IT Compliance Strategy ,GMP/ DI Monitors & Controls.
  • Computer System Validation, Backups & Retrieval, Microsoft Azure, O365 maintenance & controlling.

System Engineer

Wockhardt Ltd
06.2016 - 03.2018
  • Support to manufacturing site IT related activities.
  • IT Infrastructure & Support lead.
  • Manage the deployment, Monitoring, maintenance, development, upgrade, and support of IT systems, including networks, data Centres, Servers, PCs, Operating systems and associated hardware's.
  • Ensure the efficient utilization of IT resources – including personnel and equipment – across the organization.
  • To initiate/lead/perform the failure investigation as SME, and support the investigation team in all functional areas.
  • Executing, Reviewing and approving validation documents in accordance with company policies and procedures.
  • Execute/ Review Validation Plans, Test Plans, Test Summary Reports, Validation Summary Reports.
  • Well intended with use Data management system (DMS), Learning Management System (LMS), Track Wise QMS system, Laboratory Information Management System (LIMS), GAP analysis, Change control, GxP Assessment.
  • IT Infrastructure Management, Network Administration
  • Computer System Validation, Backups & Retrieval.
  • Support to Quality Control / Quality Assurance & Manufacturing functions
  • Support to Quality Control, Quality Assurance and Manufacturing related instruments / Equipment's
  • Responsible for User Management, Admin control, Backup and Data security of all Workstations/Computers used in GxP environment.
  • IT Infrastructure implementation as per 21CFR PART11 &; Anex11, GAMP5 compliances in QC Lab and other Manufacturing area.
  • Training & Audit Supports to Manufacturing Locations
  • Ensure adherence to IT Infrastructure compliance with adequate and accurate documents.
  • Demonstrate compliance to the established policies, Guidelines and standard operating procedure.
  • Audit and IT Support to all India manufacturing locations on IT Infrastructure, Compliances, Documentation and training.
  • Preparation, Review and Training of IT SOP's/Plans.
  • Represent Site IT in External/Internal Audits.
  • Projects Management and Support to Corporate IT
  • Work with stakeholders to define business and systems requirements for new technology implementations.
  • IT Vendor Management, Procurement of IT Systems and software's Highlights.
  • Manufacturing Track N Trace System Project Implementation, QC HPLC Chromeleon Project initiation.
  • Responsible for all Administrative and user management activity of PLC / SCADA and HMI systems
  • Responsible for participation in Investigation as a team leader or team member.
  • Review of Quality Management system documents (i.e. Change Controls, Deviations and CAPA etc.).
  • Trained users on the system implication and provided an independent oversight about an impact of 21 CFR Part 11 regulations.
  • To coordinate with cross functional departments for procurement of new equipment, technical discussion and validation activity.
  • To assist relevant department during DQ, IQ, OQ, and PQ for all equipment / systems.
  • Responsible for quality management system with respect to engineering procedures and systems.

Technical Support Executive

Digicall Teleservices Pvt Ltd
03.2014 - 04.2016
  • Managing sql database server and backup point.
  • Managing & Maintenance of Active Directory,Dns,File serve
  • Creating Group policy as per company norms
  • Network performance Monitoring and Optimization of server
  • Creating E-mail Id of user in Postmaster Enterprises
  • Managing and maintaining Mail Server
  • Installing & Monitoring Symantec Antivirus Server and Client
  • Installing & configuring windows xp ,vista, 2000 and windows 2003 2008 R2
  • Installing, configuring and troubleshooting of Ms outlook 2003 and 2007,2010
  • Installation and troubleshooting of local and Network printer
  • Remotely supporting other branch of company
  • Troubleshooting LAN connectivity
  • Follow up with vendors

IT Executive

Omnitech InfoSolutions Ltd
04.2012 - 01.2014
  • Installation of Active Directory
  • Addition, Creation & Deletion Of user accounts in active directory
  • Defining User Rights as Per Designation & Company Policy
  • Installing & configuring Windows XP, Windows 2000, and Windows 2003.
  • Installing, Configuring of Lotus Notes v 8.0.2
  • Maintenance of users databases replication & solving problems related to Outlook 2010
  • Installation & Configuration of Local and Network printer
  • Installing Sophos safeguard windows 7.
  • Help Remote Branch Engg to fix software problem over phone or using VNC, Netmeeting.
  • DBAN of workstations.
  • First level support for client specific application (SAP,CGate,Safeguard,)

Network & Hardware Engineer

Veltech Info services
09.2009 - 11.2011
  • Installation and up gradation of windows 2000 pro, Windows XP, Lan drivers and device drivers.
  • Installation & configuration of application Software.
  • Handling Call of Sites Related to Hardware or Software Problem.
  • Maintenance, installation and troubleshooting LAN environment, server, computers, printers.
  • Wi-Fi, Bluetooth, Windows, Cisco routers and switches, wireless network

Education

MBA - IT-Management

DY Patil University
Pune
06.2025

MCA -

IGNOU University
Mumbai

BA -

Maharashtra Board

H.S.C - undefined

Maharashtra board

S.S.C - undefined

Maharashtra Board

Skills

  • MCITP
  • ITIL Foundation V4
  • AGILE SCRUM MASTER

Personal Details

English
Hindi
Marathi

Timeline

Manager-CSV Risk Advisory

Ernst & Young LLP
04.2022 - Current

Validation Project Lead

IVYWorks Advisors LLP
08.2019 - 03.2022

Sr.Officer-IT

Fresenius Kabi India Pvt Ltd
03.2018 - 08.2019

System Engineer

Wockhardt Ltd
06.2016 - 03.2018

Technical Support Executive

Digicall Teleservices Pvt Ltd
03.2014 - 04.2016

IT Executive

Omnitech InfoSolutions Ltd
04.2012 - 01.2014

Network & Hardware Engineer

Veltech Info services
09.2009 - 11.2011

H.S.C - undefined

Maharashtra board

S.S.C - undefined

Maharashtra Board

MBA - IT-Management

DY Patil University

MCA -

IGNOU University

BA -

Maharashtra Board

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Sujit D Chauhan