Tirunavukkarasu Sivaraman

Vernon Hills IL, 510-***-****

acueov@r.postjobfree.com

Professional Summary:

** ***** ** ** ********** with strong knowledge in Compliance Management,Quality Management, Project Management, Program Management, Change Management, Validation Process Management, Strong customer relationship management skills, Governance, Managing stakeholders, scope, resource, cost, schedule, configuration and Risk Management. As part of the assignments, involved in Analysis, Planning and Scheduling, Effort Estimation, Design, Development, Testing, S/W Configuration Management, Build Coordination, Release Strategy, Release Planning, Release Scheduling, Release Roll outs and Delivery activities.

Clear understanding of the Regulatory compliance requirements like 21 CFR Part 11, GXP, CAPA and Computer Systems Validation (CSV) framework. Involved through the full cycle of software development including analysis, design, coding, testing & implementation with regard to CSV framework.

Actively involved in review and approve SOP’s and conducted training sessions on the QMS, ISPDM process and Change Management Plan to the Project Team and Work Stream Lead, Solution Consultant. Performed SOX testing during SOX Audit

Experience in interfacing with client stakeholders at Director and Senior Director level excellent inter-personal skills and possess very good business knowledge Hands-on experience in business development with detailed planning skills, has abilities to execute the plan and tracking the plan to closure. Strong employee engagement skills and has the abilities to rollout organizational change management initiatives without disrupting the business.

Extensive experience in domains like Life Sciences- Pharmaceutical, Automotive, Airline, Retail, Banking, Insurance and other Web-Centric Applications, worked with the clients like Abbott,Takeda, AstraZeneca, GSK, Med Immune, Air Canada, Ford, Caterpillar, EarthLink, eBay, Shopping.com, Amex etc.

Champion of management skills, demonstrated proficiency in leading and mentoring individuals to maximize productivity, while forming cohesive team environments.

Education:

Bachelor of Engineering- Computer Science

Bharathiar University, 1999

Certifications:

Project Management (2005) - Brain Bench

Managing People US –Brain Bench

Software Testing –Brain Bench

Computer System Validation for ISPDM-AstraZeneca

Introduction to IS Project Delivery Method-AstraZeneca

Introduction to SOX Testing AstraZeneca

Level 0: Life Sciences CCP-Assessment

Level 1: Life Sciences CCP-Assessment

Electronic Records and Information Management (eRIM) Policy

NPV Training: Using the Non-Product Validation Database

Documentation and Change Control Training

TDMS, LDMS, First Doc Reviewer and Approver Training

Computerized System Lifecycle and Defect Management Procedure

Sun Certified programmer on Java 2 Platform

Certified Java Programmer - Brain bench

Certified HTML Programmer - Brain bench

MDC Certified CORBA Programmer

PROFESSIONAL AWARDS AND RECOGNITIONS:

Jan 2016 Successful completion of 10 years in Cognizant.

May 2015: Life Sciences Certificate of Appreciation for outstanding contributions towards delivering excellence.

July 2011: Recognition Certificate from AstraZeneca Pharmaceuticals for MI-NATP Consolidation Project.

July 2009: Recognition Certificate from AstraZeneca Pharmaceuticals for NATP Canada Consolidation Project

Sep 2005: Associate of the Year from Satyam Computer Services

Professional Experience:

Abbott Diagnostics, Lake Forest, IL Aug 2014 to present

Project manager

OCM Project implementation and Run Team Application Support:

The Global Service Organization within Abbott Diagnostics currently has two production call registration systems Navigator, a Siebel solution, provides call management functionality to users within the United States and Canada and CMSNext, a custom solution, provides similar call management functionality to over 150 countries around the world. This project focuses specifically on the activities necessary to migrate ADD Canada from Navigator to CMSNext.ADD’s Global Service Organization has decided that a single call registration system will help reduce cost and provide for greater efficiency within the business and to eliminate Navigator oracle license cost and Navigator maintenance and enhancement costs. Cognizant provides the Application support and Maintenance (ADM) Services for the client. Cognizant’s approach to providing maintenance is to transition the existing applications and provide steady state support and make enhancements to the applications.

The applications include TODS, Reliability, GSR, IDEA DataMart, Cognos Reporting, NPV etc.

Responsibilities:

Identify program level risks, perform quantitative and qualitative risk analysis, generate risk response plans, monitor residual risks and execute risk reduction plans

Actively involved in conducting Training to the Business, WSL, SC regarding the

QMS Process and NPV workflow Review and approval process.

Coordinated with ADD multiple vendors Soghetti, Magenic, IBM completed the Integrated project plan and executed the same on time without any delay

Facilitating and organizing status meetings with between all vendors and Abbott business units and Abbott PMO

Involved in Project estimation and tracking of all project related activities across all business units.

Coordinate with the Change team to execute the Change in a controlled manner and update the impacted System documents and planned the dates for Build, Integration Testing, UAT, Validation Testing.

Create/Review and approval of all the Validation deliverables like Change Control Plan, Test Plan, Data Migration Plan, Change Control Report, Functional and Technical Scripts, Test memo, Production Release memo, IQ, OQ, PQ. etc. electronically in NPV.

Organize the CCB meeting to get the approval of Release to Test and final Release to Production after reviewing all the documentation with the CCB members.

Conducted daily status meeting during the Integration and Validation Testing and prepared Daily Status Report and provide to the Work Stream lead and ensure all the execution of Test Script completed in scheduled time.

Create/Review and approval of Test Summary and conclusions for this entire major project and issued the Final Prod Release memo.

Takeda, Deerfield, IL Jan 2014 - Aug 2014

Project Quality and Compliance Manager

Exadata Migration Project:

The objective of Exadata Migration project is to Install Data Warehouse Appliance and migrating existing DW and MARS processes which will affect all business areas related to the two systems; Corporate and Commercial.

This Project is to address current and future data processing needs for Commercial and Corporate, but will have potential benefits for future Clinical projects.

Data Warehouse will be able to process Finance data for reporting and analytics in shorter time and potentially increase the frequency which is the desired state.

Reducing the processing periods will also have impacts on operational support.

Less effort can be put to monitoring jobs for lengthy periods of time, therefore freeing up resources to working on enhancements and Continuous Improvement Items which will allow the Business to get more value from the Data Warehouse.

The existing old hardware (+6 years) which incurs extended maintenance costs of >$225K per year and on older storage technology that is slated to be retired

Responsibilities:

Prepared Weekly Status Reports interacting with all the vendors, Support team and Project team and present to PMO on regular basis.

Coordinate with Oracle team, Network, Security and Support team for the installation of Exadata Appliance.

Coordinate with the Offshore Development team to execute the Data Migration from current DW (8.6TBof Data) to Exadata Appliance (Oracle 11g) in a controlled manner and update the impacted System documents and planned the dates for Build, Integration Testing, UAT, Validation Testing.

Prepared/Reviewed REF (Run Entry Framework) documents with Support team

Ensure the current Business critical jobs i.e. weekly, monthly, FRE, DDD run on Exadata without any errors through Tidal.

Coordinate with support team for the successful execution of parallel Testing in Exadata and current 10g to compare the performance gains

Logged and tracked all the issues identified during Testing and ensured that all the defects are closed as per the time schedule.

AstraZeneca, Wilmington DE Feb 2012 - Dec 2013

Senior Validation Process Manager

AZ BAU TOP Validation:

This Project is to Provide the entire validation support for BAU (Business As Usual Projects) for AZ for all the Work Streams Finance, Purchase to Pay, Order To Cash, Supply Chain Manufacturing Quality, Enterprise Asset Management, Business Warehouse and IT.

There are different type of project namely Monthly Patch Release, Emergency Priority Release, Emergency Immediate Action, Master data, Report projects and Major Projects.

The process to be followed for this different project are defined and approved in SOP and Change Management Plan.

For any change to the validated system a separate clarity ticket will be created and tracked each and every stage of the project.

Responsibilities:

Generate and maintain the entire life cycle of User Requirement/RICEF/Test Script/Test Condition numbers from newly created to obsolete or deferred stage.

Send Notification regarding the Emergency Projects to all the stake holders of the validated system once approved by Business IS lead.

Create/Review and approval of all the Validation deliverables like Change Control Plan, Test Plan, Change Control Report, Functional and Technical Scripts, Test memo, Production Release memo etc. electronically in TDMS for Patch, Emergency and Weekly Release

Analyze and approve the reason for failure during Validation Testing and ensure it is properly documented in Change Control Report and issue the repetitive Code locks.

Ensure the scripts/AT’s/PD/CCP are pre-approved before the Validation Testing and review the executed Scripts.

Create/Review and Approve Technical and Functional Trace Matrix in TDMS

All the Validation documents are Retrieved and Archived when needed during the Audit Process.

As a SOX Tester involved in testing the SOX controls for other validated application in AZ.

Name: AstraZeneca, Wilmington DE

Regulatory Compliance Manager

Client Description:

AstraZeneca is a global research-based biopharmaceutical company. AstraZeneca’s skills and resources are focused on discovering, developing and marketing medicines for some of the world’s most serious illnesses, including cancer, heart disease, neurological disorders such as schizophrenia, respiratory disease and infection. AstraZeneca employ over 61,000 people (46% in Europe, 24% in the North America, 7% in Latin America and 24% in Asia, Africa and Australasia).

EUR-NATP: European North America Transaction Processing Mar 2011 - Jan 2012

This is the consolidation of ERP Systems from MedImmune Cambridge, UK, Nijmegen, The Netherlands and Speke, UK Sites into the North America Platform.

This will require integration of SAP functionality used at the MedImmune site in Cambridge, UK, Nijmegen, The Netherlands and Speke, UK Sites with functionality used by US Operations within the mySAP ECC 6.0 and supporting applications.

Additional functionality required for unique MedImmune Cambridge, UK, Nijmegen, The Netherlands and Speke, UK Site business operations, will be added to the US mySAP.

A single mySAP instance (North America) will exist, with unique company, plant and cost center codes for both the AstraZeneca US, MedImmune US, AstraZeneca Canada, and MedImmune European Site Operations.

MI-NATP: Medimmune North America Transaction Processing Jan 2010 - Feb 2011

The Global Fast Forward Program for AstraZeneca has developed a strategy to reduce the number of ERP Instances from 27 to 3 by the end of 2013.

In The North American ERP Hub, AZ Canada completed its integration.

MI NATP, MedImmune Integration into North American Transaction Processes is next ERP instance identified to be integrated.

The scope is the Integration of the MedImmune business into the North American Business Process/Platform based on the existing Americas ERP Hub Environment meeting the unique/critical MedImmune business needs as identified in the Gap/Fit Gap Assessment Phase, completed in November 2009.

Synergies in the business processes and support and infrastructure savings will be realized with other intangible benefits.

It will be reducing the maintenance of two separate application and hardware systems and integrating business processes, where possible, into a common platform.

NATP: North America Transaction Processing Mar 2008 - Dec 2009

NATP is the consolidation of AstraZeneca Canada and AstraZeneca US Business to achieve regionally consistent business processes & associated shared services with a consolidated IS platform based on the existing US environment.

This will require integration of SAP functionality used at the AZ site in Canada (AZC) with functionality used by US Operations within the mySAP ECC 6.0 and supporting applications

Additional functionality required for unique AZC business operations, will be added to the US mySAP.

A single mySAP instance (North America) will exist, with unique company, plant and cost center codes for both the US and Canadian Operations.

Responsibilities:

Actively Participate in the Project Status meetings and provide suggestions and guidance to perform the implementation in a controlled manner.

Gathering & documenting requirements from various business work stream FIN, OTC, PTP, SCMQ, BI, IS

Trained the MedImmune Business, development team and QA group regarding the AZ’s process

Coordinate with PMO, Development team and Architect group of AZ and MedImmune and facilitate the creation/update, review and approval of Regulatory Impact Determination, SOX & Finance Control Impact Determination and other ISPDM deliverables which includes J1U01 User Requirement Specification, PL150 Blueprint Documents, System Component Categorization, Configuration Specification, Functional Specification, and Technical Design Specification.

Performed Functional Risk Assessment using RBTA (Risk Based Test Approach) and suggest the appropriate Testing for the validated system.

Create/Review and approval of all the Validation deliverables like Change Control Plan, Test Plan, Data Migration Plan, Change Control Report, Functional and Technical Scripts, Test memo, Production Release memo etc. electronically in TDMS.

Coordinate with Service management team, Business, System Owner and Development team and other vendors acted as a single point of contact to AZ for the review and approval process electronically in TDMS

Create Review, Upload and approval of Validation deliverables CVP, CCP, PD, DTP, TP, UAT, Functional and Technical Scripts in TDMS.

Monitor and supervise the day to day activities of team members and ensure their work Products are adhering to defined process and standards.

Ensure Code lock to Test and Code Lock to Production memo issued and the final approval of CCR done by CCB chairperson and finally make the CCR Effective and close the documentation.

AstraZeneca, Wilmington DE Nov 2007 - Mar 2008

IT Validation and Compliance Manager

AZ DataMart:

The objective of Data Mart program to build an enhanced information platform that will support and deliver the next generation analytical capabilities for the US Commercial organization and provide actionable insight on mobile devices (iPads) to Field Sales personnel (~ 8000 users).

The primary focus of this project is the migration of Sales and Marketing data which includes the following datasets Targeting, Alignment - Current, Future & Historical, Segmentation, APLD(anonymous patient-level data) xponent - Plantrax & Prescriber Dynamics weekly & monthly, FSIP (Field Sales Incentive Plan)- Goal & Performance, Resource Time, SCU - Sales Credited Universe FTP -Finger Tip Formulary, Activity -CSA Targeting.

The data comparison was performed at various layers i.e. NGW Data warehouse, NGW Datamart, MicroStrategy, SIMON (iPad App) based upon the application and business rules.

Finally the AZ Business ensures the MSTR/dashboard(IPad) reports created based on the requirement with the following parameters Selling teams i.e. ONC, Diabetic, PC1,PC2,CNS,CVSpecialty Markets/Brands such as Symbicort, Crestor, Brillianta, Nexium, Onglyza and functional teams such as PSS,CSA,DSM are correct.

Responsibilities:

Identify program level risks, perform quantitative and qualitative risk analysis, generate risk response plans, monitor residual risks and execute risk reduction plans

Prepared Weekly Status Reports interacting with all the vendors, Support team and Project team and present to PMO on regular basis.

Establish information and communication needs of client stakeholders and ensure seamless timely information distribution, review technical designs for scalability, performance and robustness

Coordinate with the Offshore Development team, Testing Team and PMO to execute the Change in a controlled manner and update the impacted System documents and planned the dates for Build, Integration Testing, UAT, Validation Testing.

Prepared/Reviewed the UAT scenario with the IS and business team and obtained approval.

Logged and tracked all the issues identified during UAT session and ensured that all the defects are closed as per the time schedule.

Conducted the UAT working session for all the modules and got the final approval and ensure all the changes are migrated to Prod environment.

GlaxoSmithKline, King of Prussia, PA May 2007 - Nov 2007

Project Manager

Legacy Finance Simplification:

Legacy Essbase 9 is an application for Capital Reporting which is currently running on the legacy platform. It combines the financial transaction data coming from different source areas in Essbase cubes and allows users to drill down data across dimensions and to get the view of data.

PIP tracking tool facilitates the requests and approval of Capital Project Investment Proposals (PIPs) for GSK R&D.

It also facilitates the creation of Capital Authorization Numbers (CANs) by R&D Finance.

The goal of this project is to transition

The Legacy Essbase 9 (used for monthly consolidation, management reporting and budgeting for capital expenses) to the R&D Hyperion Essbase 11

PIP tracking to move to the un-supported (Win 2003) to supported (Win 2008) server

Decommission the Legacy Essbase 9, AutoSys, Finance Data Warehouse (FDW)

FWS

AutoSys (scheduler) and WebLaunch to move to Flux

The Estimated TCO cost per annum for the current systems Essbase, Autosys, FWS is £111k, £40k and £31k.

So the net savings of this project after implementation is £182k

Responsibilities:

Prepared the Business Rationale and SG1 slide pack presented to the PRB Leadership meeting and obtained the SG1 approval to proceed to SG2

Identify the key stakeholders BSO, PO, BC, SO and interacted with them on this proposals and get their approval

Analyze and manage customer support needs. Engage with senior executives at the clients’ organization to understand their pain points, form teams within Cognizant to provide solution.

Direct the team till the solution is delivered and accepted by customer

Analyze and assess the scope, develop estimates, deliverables and resource requirements to chart out program schedule

Perform project reviews for each of the projects within the program with respect to Scope, budget and schedule

Provide guidance to the project managers and other Technology Leads to ensure that the quality, schedule and budget goals are met

Identify program level risks, perform quantitative and qualitative risk analysis, generate risk response plans, monitor residual risks and execute risk reduction plans

Prepared Weekly Status Reports interacting with all the vendors, Support team and Project team and present to PMO on regular basis.

Establish information and communication needs of client stakeholders and ensure seamless timely information distribution, review technical designs for scalability, performance and robustness

Conducted Workshops at various levels involving all vendors, stakeholders to get input on the mandatory SG2 deliverables such as QRC plan, System Definition, GXP Risk Assessment and completed the documentation

Presented the SG2 to the PRB Leadership meeting and got approval for this project to start the development activities.

Cognizant Tech Sol US Jan 2006 – till date

Satyam Computer Services Oct 2002 - Dec 2005

Silverline Technologies Sep 2000 - Oct 2002

Kay Software Inc. CA Dec 1999 - Sep 2000

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