Validation Test Lead

Vijayalaxmi Shanmugam

804-***-**** (Cell)

*********@*****.***

SUMMARY

** **** ***** ** ********** in IT as Validation and Quality Assurance - tester, technical analyst, test lead and test manager

11 plus years of experience in Life Science – Pharmaceutical projects domain working with clients including Phase Forward, AstraZeneca, Abbott, Alexion Pharmaceuticals and Nanostring Technologies

Extensive experience in handling Clinical, Regulatory, Operations, Commercial, Medical, and Quality applications in Life sciences industry

Expertise in Project planning, Estimation, Validation Plan, Test approach, Test script creation, Dry run and Test execution, Test summary, Defect Tracking, RTM and Metrics reporting

Expertise in regulatory guidelines including 21 CFR part 11 and 21 CFR part 820

Expertise in end to end testing including HW IQ, SW IQ, OQ, PQ, UAT and Post production testing

Comprehensive knowledge of the methods, techniques, and process of system validation and verification

Excellent understanding of Waterfall and Agile methodologies

Experience in managing projects from the customer location.

Good understanding of the life sciences industry standards including SOPs, GDP, GLP and GMP

Experience in Data migration and Disaster Recovery testing

Has supported multiple projects in UAT

Expertise in Requirement Analysis and Risk Assessment

Experience on tools including Quality Center, Toad, VSS, and knowledge in QTP and Load Runner

Good experience in testing and handling GxP and non GxP applications

Experienced in SOX Audit testing and facilitating KPMG Audit

Experience in validating various COTS product including TrackWise, SAM Track and Inform.

Experience in coordinating with vendors for defect fixing and implementation

Coordination with business teams for requirement understanding, clarifications, status reporting and project planning

Over 8 years of experience in leading and managing a team of 20+ members

Handling and leading multiple testing projects at onsite and offshore

Hands on experience on Stored Procedures (SP) using PL/SQL

Excellent Analytical, client interfacing and team handling skills

TECHNICAL SKILLS

Testing Tools/Frameworks:

Quality Center, Quick Test Professional (knowledge)

Operating Systems/Languages:

Windows 10/7/XP/Vista/2008, iOS 4 & 6, SQL, Java, VB

Database

Oracle 8i/9i/10g,SQL Server 13.0

Documentation Tools:

MS-Office, MS-Visio, MS Project Plan

Web Technologies:

HTML, XML

Other Tools:

VSS, Trial Track, Toad

EDUCATION

Bachelors in Information Technology

Madras University, India

TRAINING

Cognizant trainings on SDLC, 21 CFR Part 11, Validation and GxP compliance.

PROFESSIONAL EXPERIENCE

Client: Nanostring Technologies, Seattle, WA Apr ’17 – Till date

Role: Validation Lead

Project: NanoString Technologies (NASDAQ: NSTG) is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications. NanoString technology uses unique color-coded molecular barcodes that can hybridize directly to many different types of target nucleic acid molecules, making it ideal for a range of discovery and translational research applications.

Responsibilities:

Understand new Medical Tools

Write Validation Plan for several Medical tools

Prepare a high-level User Requirements document

Write Validation Protocols and execute the test results.

Prepare Validation Reports

Facilitate PreMarket Approval (PMS) submissions

Implement the understanding of FDA 21 CFR Part 814 and 820

Manage creating, modifying and routing documents for approval in Electronic Document Management System such as EDMC

Client: Alexion Pharmaceuticals, Cheshire, CT Jan ’16 – Oct ‘16

Role: Validation Test Lead

Project: Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States and European Union for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development.

Responsibilities:

Provide Project estimation, proposal and inputs on project plan

Handle resourcing, Status reporting, project delivery and escalations

Requirement Analysis, support in Validation Risk Assessment

Coordinate and interact with Business teams, System Analyst and project teams for requirement, clarifications and sign-offs

Coordinate with offshore team for Project execution and work allocation

Prepare / review Validation plan, Test approach, test case, test summary, defects, RTM and test memo

Create and execute System test scripts, IQ, OQ, PQ and UAT

Ensure GDP and 21 CFR part 11 compliance

Perform Regression, UAT testing, BAU and post production testing

Analyze RFCs for testing scope

Coordinate document approvals, sign-offs and archival

Assist in FDA / regulatory Audits as required

Coordinate with vendor on clarification and defect fixes

Perform Disaster Recovery and Data Migration testing

Client: Abbott Laboratories, IL Oct’11 – Apr ‘15 Role: Validation Lead

Project: Abbott Laboratories is an American global pharmaceuticals and health care products company. CMS Next is an application built to store an end to end life cycle of Abbott Diagnostic Division (ADD)

Responsibilities:

Handle the Test Protocols for a new version of the application – CMS Next under ADD.

Estimate and propose automation.

Present Weekly, Monthly and Annual status reports and metrics

Provide inputs / guidance to the project team on critical issues

Ensure GDP is followed

Responsible for defining process improvements including guidelines, templates etc.

Follow 21 CFR Part 11 compliance in all Testing Activities

Trackwise Testing – Addition of new workflows to Trackwise application

Performed OQ testing on SAP Work Streams

Conduct weekly team meetings with the team

Handle resourcing, project delivery and escalations

Provide inputs for testing related SOPs

Interact with offshore counterparts for smooth project execution

Conduct internal Audits and Assist in FDA / regulatory Audits as required

Coordinate with vendors for major implementations

Review critical deliverables

Create / revise SOWs as required

Client: AstraZeneca Pharmaceuticals, DE Jul ’10 – Sep ‘11

Role: SAL (Service Application Lead)

Project: OPAL is a critical set application under Global Drug Development. OPAL is a project and portfolio management system based on the Project Management Development Suite OPX2 by Planisware. More than 2000 users access the application at a time.

This tool integrates Resource Management, Portfolio Management, Demand & Supply Management etc., for AstraZeneca users. This application will replace Matrix and SPMT2. This application is FDA validated. For the security reasons, the application is deployed in UNIX environment and will soon be migrated to LINUX.

This is a business oriented application and the users ranges from Vice President of AstraZeneca to XPILS (Cross functional Program Information Leads).

Responsibilities:

Handle maintenance, testing and implementation activities.

Review documentations and other critical deliverables to clients.

Train new resources on the application and project related activities.

Facilitate audit.

Responsible to support OPAL related queries, data collection, interface related and Service Introduction activities.

Working with Business in defining the scope, handling change controls and end delivery.

Identify project risks, analyze and incorporate remediation steps.

Provide Project estimation, proposal and inputs on project plan

Present weekly, monthly status report to client

Client: AstraZeneca Pharmaceuticals, DE Jul ’07 – Jul ‘10

Role: Validation Test Lead

Project: AstraZeneca is one of the world’s leading ethical pharmaceutical companies which provides innovative, effective medicines designed to fight disease in important areas of medical need: cancer, cardiovascular, central nervous system, gastrointestinal, infection, pain control and respiratory.

Computer Validation Group (CVG) group provides much of the validation and compliance-related services for HQ in collaboration with the QA organization. CVG team is responsible for providing services, tools, support, and training related to IS Security, Disaster Recovery, Business Continuity, Risk Management, and Computer Validation, IS Compliance, and IS Quality. CVG also plays a key role in global and local ERES compliance initiatives. This Group works with individuals and teams across all IS, as well as across the business areas within AstraZeneca US.

The highest priority of the CVG team is to integrate the required technical operating processes into the normal system life cycle activities, thereby enabling delivery of high quality, secure, and validated systems in the most efficient way possible.

Responsibilities:

Lead the onsite and offshore validation team

Conduct meetings with Change Control Board members to approve change releases.

Create, execute, review and approve validation deliverables (such as Validation Plans, Test Plans, Test Scripts, Reports, and other supporting documentation)

Administer the server for Mercury Quality Center, create and maintain new projects in Quality Center.

Onsite Test Lead and coordination of testing activities with offshore.

Perform SAP testing in both functional and technical areas.

Create manual test scripts for the Change Requests of Non-SAP applications.

Create automated test scripts for regression testing of TDMS application, execute functional test scripts for the Non-SAP application patches, review pre-execution test scripts and post-execution test scripts of SAP application and review Change Control Forms.

Perform System and regression testing

Attend status calls with the project management team to update on the progress of the project

Communicating with the Business and the Application Team to understand the requirements

Getting clarifications addressed from the client

Create and execute test scripts for QA TrackWise

Responsible for on time deliverable

Attend client meetings

Reviewing Test Scripts based on GxP standards

Preparing Summary report and Sign off documents

Perform SOX Audit for various applications and facilitate KPMG Audit

Test management activities, project tracking, status updates.

Client: Phase Forward Apr ’05 – Jul ‘07

Role: Quality Analyst

Project: Phase Forward’s well-defined methodology for the entire life cycle of the data collection and management process is broken down into three main parts – Fast Start, Fast Forward and Fast Lock. The project involves Clinical Trial development/customization activities in InForm™ base product. The entire process involves customization of various modules in InForm™ like rules, help documents, sites, users, system configuration etc.

The project involves detailed review on each clinical trial customized for various clients. The various modules implemented for any trial will be tested to verify that the development meets the client specification. Once the customization is through, the team does an integration testing and sends the tested source files and test reports.

Inform tool validation.

Inform is an EDMS tool used for capturing CRF data during clinical trials. The Inform product was developed by Phase Forward and is customized to various clients including Genzyme, Schering Plough, Merck, J&J, GSK, Lilly based on their needs and specifications. Each customized Inform product must be validated against the requirements.

Responsibilities:

Prepare estimation, perform testing and technical reviews.

Handle daily deliverables and its issues.

Send status report on weekly basis.

One point contact and support for Audit and training related activities.

Validate TrackWise application

Create and execute OQ

Create Test summary and Traceability matrix

Implement Fast track and Fast forward trials using dump (IQ)

Analyze user and functional speculations

Track defects in Trial track and participate in defect review meetings

Train new team members in Inform product and testing

Track and maintain documents in VSS

Review executed test scripts

Coordinate with onsite leads for clarifications and status

Manage work allocations

Lead 25-member testing team

Create metrics and track on time deliverables

Client: Kardex Remstar International Aug ’04 – Apr ‘05

Role: Developer

Project: Kardex is one of the leading Industrial Warehouse Equipment Manufacturer in Europe. The system caters the need of automated accounting management against storage, materials handling and retrieval (Storage Administration, Purchase Order, Quotation and Sale Order).

Responsibilities:

Develop and debug Stored Procedures (SP) using PL/SQL

Understand user requirements

Analyze data for accuracy

Report issues and coordinate with client

Perform root cause analysis in case of incorrect data

Troubleshoot issues with IBM team

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