Page | 	1  	
 
 
                                                                           	      	   Resume	 	
                        	
  	 	                     	 UMESH RAJANI	 	
                                    	  Ad	d – 40	3 A, Kenora	 CHS	,  	
 	            	      	  Hira	nandani 	Estate	, Th	an	e (West	)-400607	 	
      	                                                                                                       	 Email Id	-umesh.rajani@hotmail.com	, Mo 	– 9589175332	 	
 	
Professiona	l Summary                      	                           	                                         	            	               	                                    	                  	 	
 
Engineering graduate with post graduate in operations management having 1	3 plu	s years of technical sound 	
expe	rience	 in the 	Pharma,	 Life	science	 and	 Medical devices 	industry 	delivered	 projects	 und	er Manufacturing IT	, 	
SAP	 and 	Digit	al systems.	 	
       	Currently working with a 	digital	 enhancement project	 as a 	Lead 	– IOT Projects	 in Life science 	includes	 Project 	
management,	 Gxp 	Assessment,	 CSV	 Validation	 (Agile.	 Waterfall	, V	- Model	), Quality 	Inspection,	 Electronic 	
compliance,	 TQM	 and 	Digital	 Transformation	-based	 Projects.	 	
 
Professional Skills	 	
Computerized System Va	lidation	 (CSV) 	- Gaps Assessment , Legacy Assessment and Mitigation approach , Gx	p 	
ass	essment,	 Validation Master plan , Validation 	Methodologies ( Waterfall ,V model , Ag	ile a	nd GA	MP 	3,4,5 ) , 	
Testing 	Tools ( JIRA , 	XRAY ,q	Test ) , 	Vendor	 Assessment ,Validation deliv	erables ( P	VP ,URS , FRS , CS , DS , FRA	 , 	
FAT, SAT	 , Test	 plans / 	Scripts 	,RTM, Validation summary reports) ,	 Change control, FMEA , Deviation, Inci	dent 	, 	
RCA	 ( 5-Why ,Brainstorming , Fish bone ) ,CAPA management, SOP Harmonization , Retire	ment plan , Training	 	
management , IT security policy and their configuratio	n , D	ata backup ,SQL database, Server validation ,	 	
Inventory	 management.	 	
 
MES 	an	d Cloud	-based	 validation 	projects	 - CaliberEBMR	, Siem	ens 	Opcentre, Werum	 PAS X	, Emerson 	Synade,	 	
Upgradation 	(Compression,	 Coati	ng,	 Capsule	, HSMG, FBD, Blender	), Packaging	 line	 (Line 	-: CVC,	 Countec, 	
Sterline,	 Groninger)	. Track and Trace 	 (SAP ATTP	 , Jekson ,Cognix , ACG, Optel 	) , Reports Utility software 	(Batch 	
, audit ,	 alarm 	, trend analysis), 	Water system	 , Warehouse Management	( Pi SCADA	 , Col	d Room an	d EMS 	
software	 ) , 	Lab 	Application	 (Labware LIMS , Sample Management , Autoclave, 	Dissolution test apparatus , 	
Disintegration t	est apparatus,,	 Analytical balance	 , Weighing bala	nce ,pH meter)	 ,Document M	anagement 	( 	
Ada	ptiv , 	EDMS, 	Master contro	l , Orac	le sui	te),	 Cloud	 Utility	 (Backup	 and	 Restoration) 	, Lin	e Performa	nce 	
improvement , 	bus	iness Analytics and plant automatio	n, Power e	fficienc	y software	(Honeywe	ll , Allen Brad	ley 	
Plex),	 Pharmacovigilance	 (Clearin	g house	, Oracle 	Argus	). 	
 
Projec	t Management	 Digital 	Tool	 – Rall	y, JIRA,	 Confluence,	 Xray, qTest,	 HP	-ALM,	 LMS, 	Iris 	tool,	 Track	wise,	 DMS	, 	
Adaptiv	, Lab	ware	 LIMS	, SharePoint	, E logbook	, Honeywell	 forg	e (Power	 Saving	), batch 	tracking	, SAP A	TTP , 	SAP	 	
SOLMAN	 (ITSM	 and	 PM)	, EBMR 	(Werum	 PAS X	, Siemens 	Opcentre	, CaliberLIMS	, Emerson Synade	), ELN and 	
Empower	, MS o	ffice suite.	 	
 
Regulatory 	Audit	 and	 Compliance	 - 21 CFR part 11, 210, 211 and 	820,	 EU Annex 	11,	 GAMP 	Cat	egorization,	 SDLC, 	
ICH	 Q9	 & Q	10, PIC	/s and	 ERES ,	 ISO	 13845 , ISA 88 & 95 , Site 	Review (	System & Process ) , Market Complaints	 , 	
483 observations 	, Internal	 and	 Extern	al audit (Audi	t Faced 	- USFDA	 , WHO, 	MHRA	 ,TGA	 & ANVISA	 ). 	
 
Pharma Manufacturing and 	Total 	Quality 	Process 	– Quality 	Review	, Quality 	Inspection 	, S	OP Harmonization , 	
Audit 	Strategy 	, Data integrity 	, BMR Review and 	Improvements,	 Manufacturing process improvements	.

Page | 	2  	
 
Achievement	s                  	     	                                                                                                     	 	
• Successfully 	implemented	 and 	Validated 	Labware	 LIMS	 V6 and 	V7 enhancement 	projects	 at US sites 	of 	
Johnson 	& Johnson	  	
• Successfully faced 	5 USFDA	, 2 MH	RA	, 2 ANVISA	, 1	 TGA	 and 	1 WHO	 in my 	professional	 tenure 	 	
• Performed gap assessment across Glenmark major site	s and implemen	t compliance successfully for 300 	
var	iou	s ob	servations 	with 	proce	dur	al controls in 67 SOPs	 at 	Glenma	rk 	Overall sites.	 	
• Implemented cont	rols 	on packaging machines which reduces market complaints trends to the level of 80%	 at 	
Glenmark Over	all sites	. 	
• Implemented strong architectu	re of 3	1 tan	ks and s	teri	le line 	pro	jec	ts across sterile plants which reduce the 	
costs to 1/4	th of actual 	machine (	i.e.,	 3.5 Cr instead of	 14 	Cr) taken	 from OEM	 at 	Emcure 	Pharmaceuticals, 	
Pune	. 	
• Implemented 	397 FMEA	 along with 	Vali	dation 	of 	131 Gxp 	systems	 in 1	st and 2	nd Phas	e reme	diation 	activities 	
for	 existing manufacturing system 	as int	erim	 controls of FDA 	response a	t Emcure 	Pharmaceutica	ls, Pune	 	
• Su	ccessfully completed 	Upgradation	 and 	Validation 	Project	 of 	121	 non	-compliance system	 of 	OSD,	 harmone 	
and parental	 as per 21 CFR p	art 	11 FDA 	guidelines 	as a	 response of 483 	observation	s at 	Sun 	Pharma,	 Halol	  	
• Successfully com	pleted project	 of m	odi	fication	 and Validation	 of software of cotton inserter machine from 	
single track to double track mac	hine with covering of 21CFR annexure whi	ch m	akes company 	output rises 	
from 120 BPM to 170 BPM	 in 	Hetero	 Drugs, Hyderabad	 as 	an	 operati	on excellence project	 at CVC 	
Technologies,	 Taiwan	. 	
• Successfully 	completed project o	f packaging lines including Track and Trace systems along with 	modification	 	
of 	coun	ter software 	for tablets to reach to the speed of packaging lines 	upto 180 BPM 	in 	Lupin	 Ph	arma	 	
Indore,	 Hetero 	and Natco Pharma 	Hyderabad,	 Mylan	 Indore 	as 	an	 operation excellence project	 at CVC 	
Technologies,	 Taiwa	n. 	
Award	ed	 -: 	
• 	Given	 “On	 spot te	am award	 - 202	2” by 	TCS	 Global IT quali	ty. 	
• 	Given	 “On	 spot te	am award	 - 2023”	 by 	TCS Rnd 	and L	ab Team 	– JnJ 	Account	. 	
• 	Given 	“BPS Champi	ons 	League	 – Team Award	” by TCS	 Interactive.	 	
• 	Globally Recognized as 	“Best	 Initiative of the Year 	-2021	 & 	2022”	 by Glenmark Global IT 	quality.	 	
• 	Got awarded for Succ	essfu	lly completion of “	CSV proj	ects for sterile and OSD 	“by	 Emcure 	Pharma.	 	
 
Professional Expe	rience	           	                          	     	        	                                    	                        	13	 years	 	
Company	 	  	- 	Tata Consultancy 	Servic	es 	- (March 	22 to	 till 	date)  	       	                           	  	
Designat	ion	  	- 	Lead	 Quali	ty –  Dig	ital	 Systems	 ( Validation and Compliance)	 	
 	
Responsibilities	 	
 	
• 	Working as	 a lead 	validation and	 complianc	e for	 project	 management	, revi	ew and	 approve of 	
Validation deliverables such (	CR	/VP, 	FS/CS/DS, RTM, Test 	scripts (	pre and post executions),	 VSR)	 	
in 	JIRA,	 qTest,	 XRAY,	 SharePoint	 and other Quality tool	s. 	
• 	Leading 	Quality	 projec	ts of cloud	-base	d systems like 	MES,	 LIMS,	 ELN,	 SAP	 and	 their 	enhan	cement 	
under	 life	 sciences	 account	 	
• 	Working as a project lead for a life science client to gather business requirements, SOW and RFP 
for Business Enterprise systems and their digital transformation projects. 	  	
• 	Working with internal 	and external 	stakeholder for pr	oject	 plannin	g under JIRA PM tool and 	
representing	 teams	 durin	g RFP submissions.	 	
• 	Conducting RCA sessions for Defects/	Deviation	/Change 	management 	as per bus	iness demands.	 	
• 	Leading 	the CII (Continuous Im	provement and Innovation) initiatives at 	various 	account level.

Page | 	3  	
 	
• 	Hirin	g internally and e	xternally	 resources	 for various 	healthcare	 account to meet 	business 	requirements.	 	
 	
Compa	ny	 	 -  	Glenmark Pharma Ltd 	(HO	– Mumbai)	 - (Dec 	18 to	 Ma	rch	 22	)                  	          	               	
Designat	ion	 	 - 	Manager 	– CQA 	(Quality	 System	s and Internal 	Audit)	 	
Responsibilities	 	
• Headed	 project of 	Validation of	 manufacturing	 and lab	 system across all sites of 	Glenmark 	which	 deals wit	h 	
gaps asse	ssment 	of legacy and non	-legac	y system, upgradation	 an	d imp	lement controls on 	
PLC	\SCADA	\MES	\IOT,	 recon	figuration and requalification	 of 	manufa	cturing and IT systems.	 	
• 	Work	ed	 with internal audit team to perform internal audit acros	s Glenmark	 sites for manuf	acturi	ng IT and 	
quality sy	stems and tracking for solution	s of 	findi	ng 	of audits.	 	
• 	Work	ed	 on h	armoni	zation of SOP and developing procedur	al con	trols 	in manufact	uring and IT systems 	as per 	
regulat	ory g	uidel	ine	s. 	
•  Worked	 wit	h inte	rnal and external stakehol	ders ac	ross corporate 	IT,	 ITQA an	d all 	sites	 functions	 for global 	
project requirement 	of CSV	 docume	nta	tion.	 	
•`  Worked	 with internal IT 	team a	cross sites to pe	rform and review 	of infrastructure	 qualification,	 server 	
qual	ification 	and backup & restoration a	ctivity	 of manufacturing 	and IT 	systems.	 	
•  Handl	ed	 market complaints related to process and Gxp syst	em of	 manufacturing across all glenma	rk sit	es and 	
support in their 	investigations, RCA	 and CAPA effectiveness.	 	
•  Impart	ed	 periodic t	raining on t	he subject of 	21 CFR 	part 	11,	 IT 	SOP,	 CSV 	del	iverables,	 V model,	 GAMP, 	
 Manufacturing 	compliance,	 System 	review a	nd	 Serialization project across sites	 as we	ll as at HO office.	  	
• 	Preparation	 of MIS 	presentation,	 schedule 	reporting	 and 	progress 	of project	 to sen	ior m	anage	men	t. 	
 
 	     	Company 	- Emcure Pharmaceuticals 	Ltd,	 Pune (Oct	-2017 	– Dec 2018)	 	
                     	                  	                       	Position    	- Assistant Manager 	(IT	 Mfg. 	– CSV and 	QMS	)  	
Responsibility	 	
• 	Headed 	OSD,	 sterile 	and parental 	department for all CSV activities such as 	system up 	gradation, 	testing,	 	
execution of 	document,	 documentation 	control,	 revi	ewin	g process, change	 control 	management,	 vendor 	
management,	 infrastructure 	validation, user	 man	agement and 	backup management	 activity	.  	
• 	Finalization of system architecture	 as per 21 CFR 	requirements with	 external 	stakeh	olders,	 third party	 	
vendors, perform	 extern	al audits for testing of system at vendor site and bridging the gap of user 	
requirements	. 	
• 	Handl	ed	 preparation	 of CSV	 docu	ment 	i.e.,	 Gxp 	assessment,	 21 CFR 	testing,	 Vendo	r assessment,	 Risk 	
assessment,	 URS,	 FMEA,	 ERES,	 Functio	nal a	nd co	nfi	guration	 requi	rements, IOQ 	protocol,	 Traceability 	matrix,	 	
Summary Reports 	for manufacturing system a	nd busines	s applicati	ons	. 	
• 	Work	ed	 with track wise software tools for controlling the change 	control, deviation	 for CSV doc	umen	tation 	
activities and	 also for the pr	eparat	ion of	 root cause inve	stiga	tion 	wit	h the tools of 	fishbone,	 5 whys and 	
brainstorming te	chniques	. 	
• 	Handl	ed	 pre	paration of 	Validation master 	Plan,	 IT 	SOP,	 Impact 	assessment,	 templ	ates for testing 	scripts,	 	
annexur	e and procedure contr	ols, interim con	trols 	and 	quality controls	. 	
• 	Imp	art	ed 	trai	ning of IT 	SOP, GAMP	 4 & 	5, 21 part 	11,	 210,	 211,	 Data 	integrity, EU	 an	nexure 11, t	echnical 	
presentation to the new user of system as well as inner department as a periodi	c ac	tivity.	 	
• 	Hand	led	 team 	of admin configu	ration	 management tr	acker 	and backup management 	for 	creat	ing	 new 	\ 	
resetting	 users as per thei	r access rights and a	ssigning pro	per backend activity through domain/LDAP

Page | 	4  	
 	
features.	 	
• 	Worked with	 internal 	(Corporate	 Quality a	nd 	Compliance)	 for pr	ocess continuous	 impro	vements and faced 	
external audi	ts (USFDA, 	MHRA, 	ANVISA,	 TGA)	 in this tenure.	 	
• 	Reporting 	to higher management	 by Monthly R	eview 	Meeting (	MRM), Project tracker and 	their Traceability	 	
Matrix.        	                 	                     	           	         	          	     	     	                                                           	      	                    	  	
 
              	                               	Company         	-     	Sun Pharma	 Industr	ies 	Limited 	- (Jan	 2016 	– Sep 20	17	) 	
     	                      	                  	Position         	   -     	Sr. 	Executive 	(IT	 CSV	 and Quality 	Engineering)	 	
   Responsibility	 	
• 	Work	ed	 wit	h IT	, engineering and validation team to handle up gradation project	s of	 PLC, 	HMI,	 SC	ADA of 	
manufacturing,	 packagi	ng &	 hormone 	plant 	eq	uipment’s as	 per 21 CFR part 11 guidelines	 	
• 	Work	ed 	with internal 	stakeholder for th	e identification of critical 	equipment	’s to	 perform 	Gxp	 assessment,	 	
gaps assessment and take necessary a	utomat	ion contr	ols to brid	ge t	he 	gaps.	 	
• 	Handl	ed 	ve	ndor 	services,	 FAT 	and gathering user 	requirement for	 development of 	software’s,	 the	ir graphics,	 	
thei	r functionality,	 boundaries 	scripts, security	 policies, Password	 authorization 	checks,	 Access right	s a	nd	 	
privileges,	 their repo	rts	 and testin	g of softw	are’s as per 	business requirements	. 	
• 	Work	ed	 with	 different types of 	PLC software	 (i.e.,	 GX 	Works,	 Step	 7, RS 	Logix	) and Scada softw	are (	WinC	C, 	
wonder	 ware) for checking the ladder, I/O 	testing, drawing	 verificati	on of hardware 	and	 components requ	ire 	
in the 	execution of CSV V	alidation.	 	
• 	Auth	oring 	and 	review of	 CSV 	documents,	 SOP, validati	on	 plans,	 user and	 functional 	requirements,	 part 11 	
assessments, Gxp	 assessments,	 design 	specifications,	 ris	k man	ag	ement 	plans,	 execute 	
ins	talla	tion/operation	al/performanc	e qualification,	 traceability matrices and Summary report.	 	
• 	Impart	ed	 training of 21 	CFR part 	11 requir	ements	, GAM	P categorization,	 upgraded 	system operation over 	
depth to the internal stakehold	ers. 	and 	bridg	e the gaps	 of u	ser	 requir	ement and desi	gn develope	d by vendor	 	
• 	Manage	 and	 execute decommissioning activities or retirement plan for th	e gxp equipment’s.	 	
• 	Work	ed	 with IT team for user 	managem	ent,	 change 	management of	 manufacturing and quality systems	 wit	h 	
Trackwise	 tools to control 	incidents,	 dev	iation and 	CAPA	. 	
            	          	      	  	 	Company  	       	-    CVC Technologies 	Inc, 	Ta	iwan 	- (2011 	– Jan	 2016)	 	
 	Designation	    	-     Sr. 	Proce	ss 	Engineer 	(Validation	 and T	esting)	 	
 	
Responsibility	 	
• 	Worked with turnkey 	PLC, 	HMI, SCADA	 and	 DCS	 software’	s (	WinCC,	 Gx works,	 GTwin, Rxlogix	) of packaging 	
and manufacturing machines 	(Bottle	 line,	 powder 	line,	 Compression,	 cartonator)	 for pharma gian	ts to	 install,	 	
commission and	 va	lid	ate the complete system.	 	
• 	Preparation of validation docu	ment	s (	URS, 	FD	S, 	FAT, SAT	, IQ, 	OQ, 	DQ, 	PQ) of	 software’s as well as machines 	
as per site documentation and 21 	CFR requirements.	 	
• 	Exe	cute machine 	testing 	plan,	 user pri	vileges 	management, Historian	 da	ta 	review, Data	 analysis of batches 	
and audit reports	, perfo	rm	ance efficie	ncy 	scheduling,	 integration	 and up gradation of 	SCADA as	 per 	
requirements 	 	
• 	Worked with chan	ge management tools t	o make changes in the software as w	ell	 as i	n requi	re documentation 	
for	 tracking the record of revision.	 	
• 	Provide	d technical prese	ntations and t	raining to 	pharma clients for	 software’s as well as whole 	line machines	 	
and support technical	ly to domestic or int	ernational clients for software and	 ha	rdwar	e of ma	ch	ines

Page | 	5  	
 	
• 	Worked wit	h c	ontrol panel designing for 	machine, 	testing,	 electric	al and electron	ics compone	nts 	checks,	 	
elect	rical drawing and pneumatic drawing 	checks,	 vision inspection 	system,	 machine design	 and system	 	
support to the clients	. 	
• 	Provid	ed	 ben	efits of software	 an	d hardware to	 the customer in terms of low power utiliti	es, high produ	ction 	
ratio,	 easy operator h	andling 	software,	 and increase operational equipment efficiency 	of systems.	 	
• 	Interacti	on 	with	 Senior level and midlevel 	management of	 domestic and international clients and present 	
complex technical explanations 	and proo	f of c	oncept to no	n-technical profe	ssional	s in a 	clear and concise	 	
ma	nner.	 	
                        	                     	     	Company 	  	-  	RITSPIN INDIA LTD	.   	-------------	(Jul	 2010	- Jun 	2011)	 	
      	 Designation     	 	-              	Graduate Train	ee Engineer	 	
Re	sponsibility	 	
• Troubleshooting 	with the 	machines, motion	 control 	devices,	 VFDs, senso	rs, Relay a	nd their 	electrical, P	&ID	, 	
schematic drawings.	 	
• Worked w	ith the IT 	Network with	 the com	munic	ation o	f PLC (	Omron,	 Mitsubishi,	 and 	Delta	), sensors	 for data 	
reco	rding and pr	inting.	 	
• Manual Da	tabase handling for the operations of parameters and validate wit	h static logbooks.	 	
• Re	view of generated data with the act	ual machine with respect to 	parameters,	 errors and critical	 ch	ecks.	 	
 	
Profes	sional Qualifica	tions	         	            	                 	                                                                 	                    	                 	      	
 	
Degree	 	Branc	h 	
/Subject	 	
Institute	 	Uni	versi	ty/Bo	
ard	 	
Batch	 	% / Grade	 	
Certific	ati	on in Digital 	
Transformati	on and Innovat	ion	 
Digital 	Strategy	 	IIM, Ind	ore	 	IIM, Indore	 	June 22 	– Dec 	
22	 	
9.9 	
           	MBA	 (Executive	) 	Operations	 	       	IMS	, Indor	e 	DAVV	, Indore	 	2015	- 2017	 	        66	 	
Bachelor	 of Engineering	 	E &	 C 	IES, In	dore	 	RGPV	, Bhopal	 	2010	 	        	72	 	
Highe	r sec	ondary	 	Science	 	2005	 	State	 Board	 	2005	 	      	  82	 	
High	 school	 	Science	 	2003	 	State	 Board	 	2003	 	        	76	 	
 
Cert	ifications	 	
• Certification of 	“Digit	al Transformation	” & “Digital Disruption and 	Transformation 	Strat	egy	” by S	impli	learn.	 	
• Certification of 	“Fundamenta	l of Digital M	arketing	” by	 Google.	 	
• Cert	ific	ation 	of “	Investigation 	and	 CAPA 	“by	 FDA.	 	
• Certification of 	“LIMS	 and their Application”	 by CDS.	 	
• Certification of	 “CSV	 & Data Integrity	 “and	 “RCA tools, Investiga	tion & Deviation Management	 “by	 USP.	 	
• Certification f	rom Global Com	pliance pane	l for s	ubjec	t “	21CFR compliance and 	dat	a analytical	” 	
• Certification 	of “	World of Co	mpliance	" and "	Manufacturing &	 Product Quality	" by FDA	. 	
• Certification of “	Six Sigma primer Certification	” by BIT Degree and Master of Project Academ	y. 	
• Certificati	on of "	QMS l	ead Au	ditor	 Cou	rse" by Udemy.	 	
• Certi	fic	ation 	of “	SCA	DA Introduction	” by Internation	al Society of 	Automation.	 	
• Certification of	 “DCA	 - Dipl	om	a in Computer Application	” (Affiliated	 to Delhi Government)	. 	
 	
Affiliations	 	
• 	Alumni Member of 	Indian Institute	 of Manage	ment (IIM	) – Indo	re 	 	
• 	Mem	ber of 	Inte	rnation	al Asso	ciation of 	Engineers (	IAENG)	. 	
• 	Member 	of SQA (S	ociety 	of Qua	lity 	Assur	ance	 ,USA )	.