Classification: Public	 	
Noida, UP, 201305	 	
9958301233	 	
https://www.linkedin.com/in/shitanshu	-kumar	-432ba376/	 	
shitanshu.singh@gmail.com	 	
SHITANSHU KUMAR	, PMP	® | ISTQB	-CTAL® | ISTQB	-CTFL®	 	
SUMMARY	 	
 
 	
 	
Certified Project Management Professional	 with over 	11	 years of experience in 	managing 	
Validation vertical for  PV organizations, 	Pharmacovigilance consulting, developing 	
Validation Plan, Protocol and Report	, and providing end	-to-end testing solutions for SIT and 	
UAT. Awarded Outstanding Team Lead for working	 as a Validation lead for successful go	-live 	
of a FDA regulated, mission	-critical GXP IT Systems 'ARISg' for top	-tier client." 	Expert in 	
authoring high level project documents like Project	 Plan, Requirement Specification, 	
Functional Specification, Design &	 System Overview document, Test plan, Test scripts 	
(manual), Traceability matrix, Test Summary report and Validation Summary report.	 	
 
✓ 	Validation performance evaluation through Key Performance Indicators (KPI) and 
continuous improvement for highest 	efficiency of Regulatory Affairs operation	. 	
✓ 	Experienced in providing training to the IT, business staff and external clients on the 
Quality process as Change Management, Problem Management, Software Development 
Life Cycle (SDLC), and Risk Management.	 	
✓ 	Exper	ienced in creating and presenting quality and test metrics/reports to the business 	
partners and senior management team.	 	
✓ 	Provide	d oversight and validation expertise during the development of new 	products	 	
and new technologies	. 	
TECHNICAL AND 	
FUNCTIONAL 	
SKILL	S 	
✓ 	Managing and developing staff, including through change and development 	initiatives,	 	
and	 providing a supportive environment to enable a motivated, 	impactful,	 and 	
adaptable team	. 	
✓ 	Good experience in authoring and reviewing of Validation Plan, Risk Assessme	nt, 	
Specifications (FRS,URS, DS, CS), Validation Protocols IQ/OQ/PQ/DMQ/DRQ, Validation 
Summary Report, SOP’s, Protocol Deviation Report, Decommission Report, Periodic 
Review Report.	 	
✓ 	Good knowledge of	 21CFR Part 11, EU Annex 11, Computer System 	Validation (CSV), 	
Requirements Analysis, Change Management, Risk Management, Document 
Management, Good Documentation Practices, GxP Processes and Regulations, Non 
conformities and CAPA, GAMP5	. 	
✓ 	Well versed with API Testing using Postman,	 Agile 	methodologies,	 Test management 	
tools	 like JIRA, HP	-ALM	 and knowledge in Software Testing Levels, Bug Life Cycle, 	
Testing Life Cycle.	 	
✓ 	Performed 	GxP	 system risk assessment, Business and Functional risk, system gap , 	
review and 	 approve mitigation action plans to ensure compliance during and after the 	
system validation.	 	
✓ 	Backed by strong credentials including an electronics degree, PMP certification (PMI) 
ISTQB certification CTAL and CTFL.

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Classification: Public	 	
 
 
 	
EXPERIENC	E 	
INSIFE	, NOIDA	 	
Validation Manager	 Sep 2022	-Present	 	
✓ 	Responsible for ensuring that the implementation of regulated systems on 	  cloud 	
Platform comply with Computer System Validation standards in terms of GAMP 5 
guidelines	. Ensure GxP process is 	followed in the project during the testing phase. 	
Reviewing Validation plan, Execution Plan, Effort estimates and Validation Report. 
Worked on PV modules like Change control, Deviation, NC, CAPA, Continuous 
Improvement.	 	
Organi	zation	al Activities	 	
✓ 	Interview 	and makes hiring decisions regarding direct reports.	 	
✓ 	Assist in coaching new hires/ existing employees in PV Safety and Reporting Systems, 
CSV, FDA, and EU Regulations, E2B R3, Risk Management, Signal Management into Data 
Management 	Leader,	 or Functional Le	ader positions	. 	
✓ 	Execute Performance and Development Management activities	. 	
 
Senior Consultant, 	CSV Validation Lead	- Jan	-2022 to 	Sep	-2022	 	
✓ 	Led 	validation of migration activities for multiple clients	 	
✓ 	Developed high	-level project documents for new IT 	systems.	 	
✓ 	Provided end	-to-end testing solutions for SIT and UAT.	 	
✓ 	Evaluated benefit and risk assessment of new technical requirements and compliances 
for pharma clients.	 	
 
BIRLASOFT, NOIDA	 	
Change Manager	 March	-2021 to Jan 2022	 	
✓ 	Managed change control 	program and assisted the board that evaluated 300 	
changes annually.	 	
✓ 	Designed metrics that reduced emergency changes by 30% and increased schedule 
attainment by 50% over 4 years.	 	
✓ 	Reduced testing by eliminating redundancy between Operational Qualification (O	Q) 	
and Performance Qualification (PQ) scripts.	 	
Validation Lead	, 27	-Jul	-2020 to 	March	-202	1 	
Leading a team for validation activities of Tier 1 client for their System Upgrade, 
Enhancements and Change Request in ARISg PV application. Prepared 	Validation Plan, Test 	
Strategy/Plan, Test Scripts/Cases, Test Summary Report, User Acceptance Check List and 
Validation Summary Report.	 	
✓ 	EMA ICH E2B(R3) 	enablement for submission 	from R2 	submission	 for Tier1 client	 	
✓ 	FDA Automated Rules 	for vaccines	 and comb	ination	 product reporting	 Go live	. 	
✓ 	Used 	HP ALM 	tool for Test Management and Requirements Gathering 	for UAT.	 	
✓ 	Lead the validation activities involved in the merger of complex US and EU regional 
Adverse Event/Drug Safety data and business rules for reporting t	he Adverse Event to 	
the Regulated Authorities	. 	
✓ 	ARISg upgrade to support eVAERS reporting and multiple enhancements	. 	
✓ 	Used JIRA for test management	 and defect management	.

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Classification: Public	 	
IQVIA, NOIDA	 	
Assistant Change Manager	 Jun	-2019 to 24	-Jul	-2020	 	
✓ 	Analysis of 	Business and Functional Change and presented to Change Control Board.	 	
✓ 	Assessing, Managing, and mitigating Risks, Root Cause Analysis and CAPA assessment.	 	
✓ 	Driving CCB meeting by presenting changes to be implemented, discarded changes and 
bug fixes.	 	
 
Validat	ion L	ead/ 	Tech 	Support Specialist	, 01	-Jun	-2018 to Jul	-20	19	  	
Supervise a five	-member validation team in authoring, execution and implementing quality	- 	
assurance and quality	-control methodologies. Ensure compliance with client QA standards, 	
federal 	regulations,	 and customer specifications.	 	
✓ 	Argus 8.1.3 upgrade, USA FD	A Combo Products / 	IND,	 and MIR Validation	 	
✓ 	Validation of Argus bug fixes and New Enhancements.	 	
✓ 	USA FDA Combo and IND changes: Business Impact, Test Scenario creation, Test 
Scenario Validation and Script Authoring, Dry 	run,	 and Formal Run.	 	
✓ 	MIR Form understa	nding, PDF comparison and impact on reporting. OQ Authoring and 	
Dry run	. 	
✓ 	Complete validation for a top 5 Pharmaceutical Argus 8.1: Involved in the complete life 
cycle of validating Pharmacovigilance / Drug Safety Adverse Event Reporting Systems 
which inclu	des:	 	
 
 	
CRESTECH SOFTWARE SYSTEMS PVT. LIMITED 	— NOIDA	 	
Quality Engineer,	 01	-Dec	-2016 to 30	-May	-2018 	 	
Worked on Oracle Argus Safety and understood its key features of like Argus Case 
Processing, Configuration and Business Process/Workflow. 	Understood various Interfaces & 	
Integrations involved with Argus Safety system	. 	
✓ 	Helped in defining the test strategy in agreement with Customer and Developers	 	
✓ 	Worked with the team in managing the tests, including planning, execution and 
reporting of test r	esults. Performed authoring, dry run and execution of Operational 	
Qualification scripts based on functional 	requirements.	 	
✓ 	Coordinated with development team on logging, retesting, and tracking 	defects.	 	
✓ 	Worked on multiple change control tasks for Configurati	on updates, E2B Reports (R2 	
and R3) and Analytical Reports	 	
GOTRUKZ.IN, NEW DELHI	 	
Co	-Founder and technical officer of startup	, Oct	-2015 to Nov	-2016 	 	
Oversee end to end process including communication, risk management and meeting with 
clients. Cross Function	al Coordination 	- Worked across internal departments to ensure 	
contracts comply with all business requirements.	 	
✓ 	Prioritization and Multi	-Tasking 	- Managed multiple concurrent processes and 	
strategically prioritized whenever necessary.	 	
✓ 	Created a B2B 	logistics company: Successfully delivered hundreds of orders from one 	
entity to another.

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Classification: Public	 	
✓ 	Adding more than 500 partners within 3 months of go live: With proper coordination 
and meetings with different stake holders, created a pool of business ready to work 	in a 	
profitable system.	 	
 	
TATA CONSULTANCY SERVICES LIMITED, CHENNAI, NEW DELHI	 	
Systems Engineer	, 20	-Sep	-2012 to 11	-Sep	-2015 	 	
Promoted to serve as lead QA tester, overseeing quality	-assurance testing and teams for 	
client software and systems development projects. Performed system, unit, regression, 
stress,	 and data interface testing. Provided client developer teams with detailed 	reports on 	
quality metrics, identified bugs/flaws and recommended fixes.	 	
✓ 	Go live of www.aspenlaw.com for Wolters Kluwer Publishers: Successful go live of 
website and mobile application for Wolters Kluwer Publishers. Despite the project going 
into well, we 	pulled the project out from danger miraculously. Documented test defects 	
and procedures to enable accurate replication and follow	-up with development team till 	
the closure of defect. Accelerated average QA testing turn	-around time by 25% or more, 	
allowing 	TCS to accept next testing project of same site on mobile.	 	
✓ 	Documented software defects using bug	-tracking system (TFS) and reported defects 	
involving program functionality, output, online 	screen,	 and content to software 	
developers.	 	
✓ 	Successful installation 	of new software on MPU in the Sear's stores: Tracking and 	
observing the network usage and status of the device connection. The project also 
included a change in technology from JAVA to Dot Net and compatibility of old devices 
in the modern technology.	 	
          	EDUCATION	 	KIIT UNIVERSITY 	-BHUBANESWAR, ODISHA	 	
Btech. 2008	- 2012	, Electrical & Electronics Engineering	 	
DAV PUBLIC SHOOOL	 HEHAL	- RANCHI,	 JHARKHAND	 	
2007 	12th	 in Science Stream	. 	
COMMUNICATION	 	✓ 	Excellent written and verbal communication skills.	 	
✓ 	Confident, articulate, and professional speaking abilities.	 	
✓ 	Quick Learner	 and risk management	. 	
✓ 	Speaking in public, to groups, or via electronic media.	 	
✓ 	Superb observational	 and negotiation skills.