1. CURRICULUM VITAE
House No: 1093, Sector 39B Saurabh Malhotra
Chandigarh -160036 saurabh2malhotra@yahoo.co.in
Mobile: 09876012207
Objective
Seeking a position as Functional or Techno-Functional Consultant to utilize my
skills and abilities in the field of Information Technology that offers professional
growth while being resourceful, innovative, flexibility and continuous learning.
Professional Exposure
 Overall 10 years of experience in IT, Pharmaceutical Industry
and Insurance/Finance Industry.
 Currently working as a Project Lead IT Manager and leading
project and validation management activities for EBR and LMS
project in Mohali location of Ranbaxy.
 More than 2 year experience in Training Management project (LMS –
Sum Total System)
 More than 1 year experience of working on MES project (XFP –
Siemens Ltd)
 More than 4 years of experience in validation activities for Customized
software development, Automated computerized systems (e.g. EBR,
LMS etc.) Conducting IT SOPs compliance audits and providing support
during external regulatory inspection (e.g. USFDA, EU, TGA-Aus.,
ANVISA-Brazil, MHRA, PMDA-Japan, etc.) preparation, remediation and
response.
 Specialties: Project Management, Validation & Compliance Specialist
experience in Computer System Validation, Infrastructure
Qualification, Regulatory and Compliance Management, Pharma IT
Solution, Business Analysis.
 Responsibilities: Responsible for technical and validation solutions
involving EBR (Electronic Batch Record) Project, LMS (Learning
Management System).
 I have good exposure across different verticals (Insurance, Finance
Pharmaceutical) for Project Management and Validation activities, IT
Infrastructure Validation, Risk Assessment, Gap Assessment, Impact
Assessment, 21 CFR Part 11 and GAMP 5 guidelines projects. Good
exposure on SDLC and V-Lifecycle model.
 Project Management :-
 Experienced in End to End project management starting from
Requirement Gathering, Knowledge Transfer, Project Plan Preparation,
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2. CURRICULUM VITAE
Identifying the Deliverables, Project Documentation, Client
Communication, Ramping the Team, Team Building, Team Motivation,
Project Execution, and Project Close Out.
 To ensure high level of compliance for computer systems, validation
requirements, CIIT Policies & Procedures to meet the regulatory
requirements and support for various regulatory & statutory audits.
 Coordination with vendors, support Teams to ensure that all the user
calls are managed within the SLAs.
 Computer System Validation (CSV):-
 Good knowledge on V-Lifecycle model for validation and hands on
experience in Verification and Validation of the computer systems such
as Laboratory Computer Systems & Business Process Systems starting
from GxP Assessment, preparation of Project Validation Plan (PVP),
Gap Analysis, Risk Assessment (System, Level and Functional Level
Risk Assessment), Impact Assessment, Traceability Matrix, IQ, OQ &
PQ Protocol & test scripts, Validation Report and System Release
Certificate as per the classification of GAMP 4/5, USFDA guidelines and
Good Documentation Practice.
 Expertise in Computerized System Validation (both Legacy and New
systems). Good Knowledge of 21 CFR Part 11 requirements in
computerized systems.
 Hands on experience in LMS (Learning Management System).
 Highlights of Completed and Ongoing Projects:
1. EBR (Electronic Batch Report) (Ongoing Project)
2. Learning Management System (LMS) upgrade (Ongoing Project)
3. Data Acquisition System (DAS) implementation
4. Enterprise Document Archival Management Systems
5. Global Vendor Management Systems
6. Attendance Recording and Access Control Systems
7. Network revamping at multiple Ranbaxy locations
 Prior Work Experience:
 Worked with Fullerton India credit Company Ltd as Branch Unit
Manager, since Aug 2012 to Sep 2012.
o Technical expertise given building and maintenance of
applications, in Intranet.
o Managing IT operations for branch
 Experience of 1.3 years Met Life Insurance as Branch Head in Sales
Department since 15 March 2010 till 30th June 2011 wherein handling
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3. CURRICULUM VITAE
a team of 7 Sales Manager and managing IT operations for branch and
help in building training software for Chandigarh region.
 Experience of 3.5 years Reliance Life Insurance as Territory Manager in
Sales Department since September-2006 till March-2010 wherein
handling a team of 10 Sales Manager and Managing IT operations for
branch
 Good exposure on client handling skills and customer eccentricity.
 Knowledge of ITIL processes.
Academic Qualification
 Post Graduate diploma in Management of Software Development
(CPMSD) from IIM-C (2014)
 PGDCA from Punjab University (2005)
 Graduation in First Division, Bachelor’s Degree in Computers (BCA)
from Punjab University (2003)
 All India Higher Secondary Education (2000)
Technical Skills
Validation/Testing : Computer System Validation
Database : PL/SQL
Reporting Tools : Crystal Reports
CMS Tool : Documentum
Project Achievement
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4. CURRICULUM VITAE
Project EBR (Electronic Batch Report) (Ongoing Project)
Team Size 7
Role Project Lead
Description Electronic Batch record (EBR) is an important part of entire
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manufacturing process as it contains the entire batch
related data. Currently all the data is filled manually and
manufacturing execution steps are controlled manually
through doer and checker concept. Initially a blank batch
production record document is printed from a controlled
system and the BPR is filled manually. Steps execution,
review workflow and all log books are filled manually.
There are few raw data documents attached (as hard
prints) to the BPR coming from some third party
applications.
Responsibilities
 Selection of key vendors and build strategic
relationship with them. To negotiate contracts and
define service level.
 To steer the internal team, multiple vendors and
multiple functions across organization to ensure
quality deliverables within deadline.
 Data Acquisition System (DAS) - Automation of
entire shop floor with a target to achieve zero
manual entries covering approx 140 machines and
weighing balances.
 Electronic batch record (eBPR) - Responsible for
automation to ensure electronic capturing of all
batch related parameters and to ensure that all
process controls are enforced. One of its kind in
India.
 Authoring , Review and approval of following
validation deliverables:
· IT SOPs Training
· Change Control Review and approval
· GxP Assessment
· Risk Assessment
· Impact Assessment
· Project Validation Plan Preparation and
Review
· User Requirement Specifications (URS)
· Functional Requirement Specifications (FRS)
· Configuration Specification and Design
Specification Preparation
· Qualification Plan (QP) Preparation
· Test Scripts (IQ, OQ and PQ) Preparation
and Review
· Requirement Traceability Matrix
(RTM)Preparation and Review
· Validation Summary Report (VSR)

5. CURRICULUM VITAE
Project LMS (Learning Management System) (Ongoing Project)
Team Size 5
Role Project Lead
Description The Learning Management System, SumTotal,
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Version 8.8 system is a Commercial-Off-The-Shelf
(COTS) system developed by Sum Total, located in
Hyderabad, Andhra Pradesh. It is designed to
identify training needs of each department
according to different job roles of employees in the
department, to collate all different departments
needs into one matrix, convert the need identified
for a specific role into individual’s need , Need
identified and approved by HOD
Responsibilities
 LMS Admin Support (Global)
 LMS Trainings for Rollouts
 Authoring , Review and approval of following
validation deliverables:
· IT SOPs Training
· Change Control Review and approval
· Vendor Survey
· GxP Assessment
· Risk Assessment
· Impact Assessment
· Project Validation Plan Preparation and
Review
· User Requirement Specifications (URS)
· Functional Requirement Specifications (FRS)
· Configuration Specification and Design
Specification Preparation
· Qualification Plan (QP) Preparation
· Test Scripts (IQ, OQ and PQ) Preparation
and Review
· Requirement Traceability Matrix
(RTM)Preparation and Review
· Validation Summary Report (VSR)
· System Release Certificate (SRC)
· System User’s Training

6. CURRICULUM VITAE
Project Data Acquisitions Systems (DAS)
Team Size 8
Role Project Lead
Description The DAS Reports, Version 2.0 system is an in-house
Personal Identities
Date of Birth : 14th January 1982
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system developed by Ranbaxy IT at DF Manufacturing
located in India. Data Historian Server captures runtime
parameters/tags values for selected equipment’s, which
are automated using PLC automation by joining their PLCs
on a network and keeps on storing the captured data in
Historian database based upon the defined interval for
data capturing. It is designed to perform the following
business functions:
a. The data captured will be used for analytical and
statistical reports generation.
b. DAS Reports shall be used to print/display
(equipment and date-time wise) data from
historian database for records and analytical
purpose. These DAS Reports can be attached
with BPR as supporting data.
c. Improvement in compliance level by capturing
and printing the runtime process data in most
authentic way.
d. DAS reports can print runtime parameters/tags
values at central printer from selected
equipment’s without configuring the PLC/HMI
program for printing.
e. Equipment’s process data can be printed at
various printers connected over network, no
need of standalone printer with equipment’s to
take print
Responsibilities
 Authoring , Review and approval of following
validation deliverables:
· Qualification Plan (QP) Review and
approval
· Test Scripts (IQ, OQ and PQ) Review and
approval
· Requirement Traceability Matrix
(RTM)Preparation and Review
· Validation Summary Report (VSR)
· System User ’s Training

7. CURRICULUM VITAE
Contact Address : #1093, Sector –39B, Chandigarh,
160036
Languages Known : Hindi, English and Punjabi
Father’s Name : Sh. Surinder Malhotra
Marital Status : Married
Sex : Male
Nationality : Indian
Passport No : K9021540
Declaration
I solemnly declare that all the particulars furnished above are true to the best of
my knowledge.
Place: Chandigarh
Date:
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