Senior IT Professional

NITIN KAPOOR

PERSONAL DETAILS

Name: Nitin Kapoor Nationality : British

Address: Postgasse 20 Phone : +41-796*-*****

Binningen 4102 Email : *****.******.****@*****.***

Switzerland Swiss : C-Permit

Career overview: Nitin is a senior IT professional and has extensive experience working in the pharmaceutical industry.

He has worked on a number of Global Pharmaceutical system projects in both Projects and Operations

organisations. He has also worked in different roles such as: Business Analyst, Team Lead and Global

Application/Infrastructure Manager and carried out a diverse range of activities such as business process

mapping; configuration; testing; deployment; training and system support.

Nitin has gained valuable experience in supporting Global applications using ITIL best practises such as

Incident and Problem Management, Change Management, Configuration and Release Management, User

Management, License Management, SLA Management and Financial Management. He has used

Business Process Re-engineering (via GAP analysis and Lean Sigma) and these have increased the usage

of the system and produced significant productivity savings.

Nitin is a qualified SAP R/3 consultant specialising in the Quality Management (QM) module (Quality

Assurance (QA) & Quality Control (QC) business processes). During his career, he has also gained

experience using the following logistic modules: Materials Management (MM); Quality Management

(QM); Warehousing Management (WM); Production Execution (PE) and Sales & Distribution (SD).

Nitin has worked in a Global multi-cultural environment where Project and Operational teams are based

in different locations and countries with multiple time zones and which operate in virtual environments

with collaborative ways of working.

Nitin has good leadership, interpersonal, team working and negotiation skills. He is customer focused

with proven problem solving skills and has worked with an impressive list of blue chip clients from a

variety of different industries and has gained a MBA from a leading UK business school.

EDUCATION

1990-1991 University of Bradford Management Centre (UK) - Masters in Business Administration

1981-1985 De Montfort University (Formally Leicester Polytechnic) - B.Sc. (Hons) Computer Science

EMPLOYMENT DETAILS

Jan 2011 - Current Novartis (Global Implementation & Support of DVCS systems)

DVCS Global Application Manager / Head of DVCS GCC, PQIT (Pharma Quality IT)

• DVCS (Digital Vision Control System) systems detect, identify and reduce artwork design errors earlier in the design life cycle.

It compares digital documents with either the finished printed packaging material or previous related artwork files, which leads

to an improvement of the artwork, file quality and lead time reduction

• DVCS consist of the 4 applications: Text Verification Tool, Graphic Verification System, Printed Packaging Material

Verification System and Artwork Verification System. These tools automate the Novartis ‘Duty of Care’ checks made to

Packaging materials (e.g. folding boxes, leaflets, foils, booklets)

• DVCS user community groups within Novartis Pharma include Drug Regulatory Affairs (DRA), External Supply Organization

(ESO), Country Pharma Organizations (CPO), Artwork Operations (AwOps), Quality Assurance (QA) and Quality Control (QC)

departments in TechOps sites

• DVCS Project Role: Team Lead for the Design and Creation of DVCS Competency Centre for 1st, 2nd and 3rd level support:

Creating a Governance structure for the DVCS GCC support and project organization

Creating DVCS GCC procedures such as: DVCS Operational Handbook; Incident & Problem Management (1st, 2nd &

3rd Level Support); Change Management; Configuration & Release Management; User Management; License

Management; Backup & Restore; Maintenance & Monitoring; IT Service Continuity / Disaster Recovery; IT System

& DVCS Application Training; Work instructions for: 1st &2nd Level support teams

Supplier selection and On-boarding for 1st, 2nd, & 3rd Level Support; Ensuring Service Desk infrastructure correctly

setup and tested (e.g. telephones, computers, WLAN, LAN); Service Desk Agents, 2nd and 3rd level support staff

recruited and trained in: DVCS applications; Global application support procedures (e.g. Incident Management);

Support tools (eg. iTool/ACMS/GCM) and Novartis Procedures (e.g. CSV, ICE, SOPs)

Creating and maintenance of SLAs / financial agreements with all Service Providers (PQIT and 3rd Level Support)

Successful Handover of Project Activities (Business and IT) into Operations at Local and Global level

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NITIN KAPOOR

DVCS Global Application Manager / Head of DVCS GCC, PQIT (Pharma Quality IT) – Continued

• DVCS Operations Role: Operational Head of the DVCS GCC, activities include:

Leading a global team of Service Desk Agents, Application Support Engineers, Quality Managers and IT Infrastructure

professionals supporting Novartis artwork applications.

Providing application lifecycle management and service management (application and infrastructure) via change

management following the Novartis standard operating procedures and policies

Presenting DVCS GCC KPI’s to the customer through monthly Service Review Meetings

Supporting Continuous Improvement activities & Reducing DVCS GCC Operational budget by 20% year on year

Managing DVCS GCC Financials (Operations budget/Rolling forecast) including all SLAs & Financial agreements

Working closely with all DVCS stakeholders in order to manage the business process and application life cycle

changes. These include the:

System Owner, Business Process Champions, Business User Communities, Business Reference Groups,

Application Support Engineers, Project & Operational Quality Managers, E-Compliance, Service Providers

(application /infrastructure /service desk/IT personnel), User Communities (Key/End Users), DVCS Global

Competency Centre, Global Packaging Strategy Competence Centre & AwOps Competence Centre

Contributing in DVCS project and change management meetings and activities including Positive Control sample

evaluations and the annual DVCS Best Practice Meetings

Working closely with Global Compliance and Validation for all validation assessments and for answers to questions

made to sites on global (GxP) applications by internal / eternal auditors

Currently involved in the planning of the DVCS tools upgrade projects and providing information to integrating

DVCS tools into the Artwork Next Generation (ANG) project

Sep 2007 – Dec 2010 Novartis (Global Implementation & Support SAP Quality Module (QM)

LI@N Core Manager, PQIT (Pharma Quality IT)

• Global team core member involved in the implementation of SAP QM (22 TechOps sites) under the project name LI@N

• Project Role: LI@N Core Manager:

Lead the Business Reference Group to discuss/approve enhancements to LI@N business template

Involved in the harmonisation of QA/QC business processes across PharmOps, ChemOps and BioPharmOps sites,

leading to a new defined standard of LI@N Core processes and functionality used by all sites. My role was to be the

guardian of this standard. This lead to transparency, simplification and best practice sharing between all sites

Worked with all stake-holders: Management team, Global project team, Local project team and support organisation

Configured and Tested the Business Process template in Novartis ERP system landscape (6 prod. ERP systems)

Formally Tested LI@N for Novartis in: ChemOps, PharmOps and Bio-PharmOps sites

Developed, Tested and Implemented new bespoke LI@N QM functionality

Worked with quality managers for validation and risk assessments on change requests

Worked closely with SISNET support organisation in order that the project handover process to sites was successful

Stats: 1600 new users, 20,000 hours of training, 1,600 technical change requests, 4800 tests executed, 10,000 user

requirements, 20,000 doc. approvals, business harmonization for all sites, finish on time, 1m CHF budget saving

• Operations Role: LI@N Core Manager:

Provided post go-live support to all implementing sites

Various LI@N Change management projects (continuous improvement activities)

Provided support and resolved issues pertaining to LI@N from various Novartis Internal System Audits

Apr 2000 – Aug 2007 GlaxoSmithKline PLC (Global Implementation & Support of ERP SAP systems in the QM module)

QM Senior Consultant / Global Team Lead, Enterprise Application Services (EAS)

• GSK uses a number of global ERP SAP systems such as SAP1, MERPS, MERPS2, BEBOP and CERPS (SAP 4.6 / 4.7)

• Approximately 15,000 users were supported in 30 sites/markets worldwide operating in multiple time zones

• Application and System support was provided 24 hours a day across 3 support centres (UK, USA, Australia)

• GSK configured the QM module and modified the SAP QM standard where it did not meet GSK’s QM requirements

• QM module is integrated within the SAP system via the MM, WM, SD, PE, PM and FI modules

• Project Role: Global QM Core Team Member:

Configured; Developed and Supported the global QM standard in the following areas: Inspection lot creation;

Recording inspection results; Inspection lot completion; Sample Management and Dynamic Modification rules;

Quality Certificates; Quality Notifications; Batch Classification; Batch Management; Handling Unit Management;

Document Management System and all GSK QM bespoke functionality

Involved in a number of site rollout implementations for GSK, Customised SAP QM; Developed new bespoke GSK

QM functionality and reports. Created and amended all relevant project documentation e.g. user requirements &

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NITIN KAPOOR

functional specifications. Performed OQ testing and helped the sites create and test PQ scripts. Developed training

material and provided training to sites. Provided on-site support and knowledge transfer to global support staff

QM Senior Consultant / Global Team Lead, Enterprise Application Services (EAS) – Continued

• Operations Role: Global QM Team Lead (EAS):

Supported the global QM user community in Incident & Problem Management; Change Management, Configuration &

Release Management and User Management procedures

Acted as QM site teleconference chairman across all sites worldwide. This forum was the governance board which

approved QM change projects; Discussed change project priorities, timelines and best practice

Used collaborative tools to brain storm ideas, discuss problems, potential solutions/enhancements, corrective/

preventative actions with sites and virtual & outsourced project teams located in different countries and time zones.

Worked with sites to produce business benefits plans for change request tickets

Change owner for approved change requests; Worked with all teams for implementation. This included:

• Writing business change request proposals, Modifying user requirements; Reviewing design documents;

Writing and executing unit & system test cases; Writing test closure reports; Training site users; Implementing

change requests to agreed timescales.

Various Continuous Improvement activities related to QM change projects and global SAP support centre

Helped formulate answers with the Global Compliance and Validation team on MERPS QM and batch management

system audit questions by internal/external authorities such as the FDA, MHRA and Global Internal Audit.

Aug 1997 – Apr 2000 Hoechst Marion Rousell (HMR) / Aventis Pharma

Senior Business Analyst / Team lead (Implementation & Support of SAP MM, WM, SD Modules & SAP Security)

• Project Role: SAP Project Core Team Member:

Project core team member for the MM / WM Modules between Hoechst Marion Rousell UK (Pre-Aventis) business

and Druid SAP consultancy during the implementation of SAP for Hoechst Marion Rousell (HMR)

Validated SAP customising in the MM / WM modules; Created bespoke program specifications; Designed data transfer

migration process from legacy systems to SAP; Created and execute test scripts; Supported key users

Created/Presented end user training in Material Management, Inventory, Warehouse Management and Purchasing

Implemented SAP security for 800 users across 3 HMR UK plants

• Operations Role: MM/WM & SAP Security Team Lead:

Aventis Pharma was formed in 1999 when French Rhône-Poulenc merged with German Hoechst Marion Roussel

Post go live: Providing 3rd level support for MM / WM modules and SAP Security using SOPs on Incident & Problem

Management, Change Management, Configuration & Release Management and User Management

Project leader: Business Process Re-engineering project for the Milton Keynes Warehouse

Project leader - COX Warehousing - Customising of a new warehouse structure, master data, activities, storage units,

stock placement/removal strategies and inventory management interfaces for the Swindon Warehouse

Project leader - Global Material Identification System (GMID) and SAP for monthly reporting to the global

Modified Credit Management (SD module) and Procurement procedures via SAP customizing

Project listed above significantly increased user efficiency, information available at hand and time saved

Liaison person for the Global SAP Team and Quality Assurance Team to meet FDA / MCHA requirements for SAP

Involved in 3 successful audits of the SAP system

Oct 1986 – Aug 1997 Various, Consultant / System Analyst / Programmer

• Worked on a number of business & application system projects using a variety of Business & IT tools including 4th generation

prototyping software for accelerated systems development, database design (eg. Oracle/MS SQL/dBase/etc) and programming

(e.g. SAP ABAP/4, ‘C’, dBase, COBOL, Pascal/Basic / Visual Basic/etc) for the following companies:

Coopers and Lybrand, Siemens Information System, AIT, Rank Xerox, Union Bank of Switzerland, Fuji Bank, Marks

& Spencer, Rosyth Naval Base, Domestic Electronic Rentals

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