SUMMARY:

• Over 16 years of experience in the IT industry
• Various roles played are Test Program Manager, Validation Manager, Test Manager, Validation Lead & Test Lead
• Managed Testing Center of Excellence (TCoE) with annual billing revenue over $5 Million. Experience in Service Initiation, Standardization & Stabilization
• Well versed in a global delivery business model, onsite & offshore engagements
• Managed customer accounts including financial, contracts, SOW, change requests, project margins/profitability
• Managed a program/project delivery and various aspects of program/project management - demand, resourcing, estimations, project planning (scope, cost, time), risk/issues, mitigations, metrics, client meetings, various status reporting
• Prepared and reviewed validation plan & risk management plan (RMP) as per GAMP 5 risk assessment techniques
• Reviewed design, user/functional requirement specifications per 21 CFR Part 11
• Performed risk assessment on user and functional requirement specifications as per RMP
• Prepared and reviewed installation, operational and performance qualification protocols (IQ/OQ/PQ) based on good documentation practices.
• Prepared and reviewed traceability matrix, validation summary report
• Performed deviation/discrepancy management and managed defect triage meetings
• Supported Production release testing, Hyper-care support after production release, Change Management
• Established various testing processes, best processes & quality standards
• Performed full range of test activities: functional manual & automation; integration, migration & UAT
• Hands-on & technically savvy; good in analytical, communication & interpersonal skills

SKILLS:

• Validation & Test Strategy, Change Management, Deviations, CAPA, GxP Validation Process, Resource Management
• Client/Server Applications, Web Applications, SharePoint application, COTS Products
• Clinical Trial Management System (CTMS - Seibel eClinical), MES system (Oracle EBS - Plan to Make, Order to Cash, Procedure to Pay), Axway Synchrony Gateway, Successfactor Learning Management System (LMS), Veeva Vault
• HP ALM, Quick Test Professional, JIRA
• Windows OS, SQL Server and some experience in Unix/Linux

PROFESSIONAL EXPERIENCE:

Confidential

Validation Lead (Onsite)

Responsibilities:

• Managed end to end Validation program for Oracle EBS Sustainment, Oracle EBS Capex project, Enterprise Middleware Sustainment, Agile PLM Capex, Veevault Functional Capex projects
• Led planning, estimations, review and status meetings, resourcing across onsite and offshore, s
• Authored Validation plan, Risk Management Plan, Validation summary report and Traceability Matrix.
• Reviewed user requirements, functional requirement and design specification and provide effort estimation for validation effort
• Performed functional risk assessment, data integrity assessment for the GxP applications
• Reviewed the validation deliverables (Plan, IQ/OQ/PQ protocols, Traceability Matrix, Test Runs, Defects, Summary) defined as per the Standard Operating Procedures (SOPs)
• Provide resource planning, project planning, support execution and
• Change Management: Support and participate complete life cycle of Problem Reports, Deviation and Corrective Action & Preventive Action (CAPA)
• Adhere to Good Documentation Practices
• Worked on major applications like
• Oracle EBS r12 - Plan to Make (PTM), Procure to Pay (PTP) and Order to Cash (OTC);
• Oracle products, SOA Suite, AIA Framework and Oracle B2B Integration
• Veeva Vault: Cloud enterprise content management platform and suite of applications for life sciences.

Confidential

TCOE Program Manager, R&D IT Val ManagerValidation Lead (Onsite)

Responsibilities:

• As a Delivery lead, oversee aspects of project life cycle (SDLC), from initial kick-off, requirement analysis, asset validation, design (translate system requirements into software design documentation), implementation phases (development), change requests management, quality assurance, UAT & legal development supports (for agency and PRC review feedbacks), development updates as per Confidential review (PDUFA), Final launch and Post-launch (hyper-care)
• Detailed Launch planning starting one month in advance, included identifying all the activities for environment readiness, application readiness, Front end readiness and launch.
• Providing direction, motivation & to the pursuit & delivery team for ensuring optimum performance. Identifies improvement opportunities, gaps, mitigation plans and suggesting process improvements
• Led qualification of automation tools UFT, Lean FT, Selenium and AppliTools for its use in validation testing
• Presented POC for mobile performance testing and automation testing
• Authored Validation plan, Risk Management Plan, Validation summary report
• Reviewed user requirements, functional requirement and design specification and provide effort estimation for validation effort
• Reviewed the validation deliverables (Plan, IQ/OQ/PQ protocols, Traceability Matrix, Test Scripts, Test Runs, Defects, Summary) defined as per the Standard Operating Procedures (SOPs)
• Worked on major applications like
• SuccessFactors Learning Management System (SAP) (SF LMS): Implementation of a software-as-a-service (SaaS), Commercial-off-the-Shelf (COTS), GxP-relevant application eCAF (eCapital Approval Form) sharepoint
• Development & QA of commercial websites for biotech./ pharma therapies products

Confidential

Validation Lead (Onsite)

Responsibilities:

• Validation Lead - Interface with all client stakeholders and testing team
• Project planning, daily tasks, project delivery, quality, and communication
• Impact and effort analysis; setting up of the testing process and best practices
• Report to client senior management - Weekly status and quality metrics
• Daily meeting - status reporting, defect triage, issues and clarification
• Project closure activities - KT and lessons learned document
• Tools: Application Life-Cycle Management 11.0, Share point
• Lead knowledge management, quality(rubrics) & estimation council initiatives
• Worked on major application like
• Lot Restriction Management System - Custom built application

Confidential

Validation Lead (Onsite)

Responsibilities:

• Program management - Delivery, demand, project planning, tracking, risk management, status reporting, SOW creation, project initiation, estimation, projections, resourcing
• Demand management - projections of upcoming projects and resource planning
• Test COE (Shared Services) - Solution test factory processes, test under management
• Test management - project initiation, planning, controlling, execution and closure
• Quality Center Support(QCtr) - Creation of QCtr project, tracking
• Quality compliance, requirements and change request analysis, impact,
• Initiatives - Portfolio analysis, test data pilot
• Worked on major application like
• Integration of patient data acquisition & management system Confidential (LMK) with the CTMS system Confidential (LSP)
• Integration testing for the PDAM, UAM, Inform and LSP CTMS system
• Subjects/ Visit entered in LMK Inform sent to LSP CTMS after applying translation rules to the AE data.
• Users provisioning from LSP CTMS system;
• Global On-Line Dossiers;
• Research Laboratory Information Management System (RLIMS)

Confidential

Validation Lead (Onsite)

Responsibilities:

• Test Manager - project initiation, planning, controlling, execution, and closure
• Delivery, quality compliance, requirements understanding, analysis, change request analysis, test impact, test design, review, execution, defect reporting, project tracking, status, feedback
• Test Lead - Functional testing, migration testing, automated testing, and UAT Support
• Peak team size of 30 testers.
• Automation - via QTP v10.0 and Quality Center v9.2, present POC, present Cognizant in-house CRAFT hybrid framework, regression candidates identification, automation suite review
• IV/FV (IQ/OQ) test script design, review, dry run, execution, coordination, issue resolution,
• Developer - Installation/setting up of POSTFIX SMTP relay/restrictions; Apache reverse proxy, load balancing, virtual hosting, forced SSL; Tomcat clustering; eSubmission to Confidential setup
• Frontend and backend testing, application server testing, and transport server testing
• Tools: Siebel eClinical, QTP 10.0, Quality Center 9.2, Terminal Server, Citrix, Exceed, Hummingbird Neighborhood; Exceed, SAS8, 9 and 9.2
• Worked on major application like
• Clinical Trial Management System (CTMS)
• SAS Clinical system for clinical trial, random code and report generation
• CTMS and Enterprise my Learning Automation
• Secure file transfer (SFT) - optimize business processes into a single, US Based, global solution for regulated and non-regulated SFT
• Serious & Non Serious Adverse Event (S&NSAEs) for clinical trials eCRF Generation - generate PDFs of completed e-Case Report Forms to support submissions, inspections, sponsor and site archival; web reporting portal for Business Intelligence COE; audit systems

Confidential

Validation Lead (Onsite)

Responsibilities:

• Reviewing URS/FRS; protocol design, execution, defect management and maintain validation testing documentation. Familiarizing validation SOPs and SDLC
• Ensuring system requirements meet quality expectations and requirements traceability
• Performing testing on Administrative Systems and IVR Systems based on written test plans
• Worked on major application like
• Interactive Voice Response System (IVRS)

Confidential

Test Analyst (Onsite)

Responsibilities:

• Design discussion, review/feedback/suggestions, testing & defect management
• Coordination with development & support, issues, retesting & their work-around
• Worked on major application like - TotaleAtlas-Applications, TotaleChecks, SECUREITeNROLLMENT, TotaleRecepts(TeR)

Confidential

QA Analyst, Tester

Responsibilities:

• QA Analyst, onsite-coordinator, tester, established the process for self & peer review
• Managed testing, estimation, planning, tracking, status reporting, risk management, scenarios
• Client interaction, defects management, test data, clarifications & team
• Involved in developing automation framework components. Identification of automation candidate, finding the data elements to make powerful data-driven scripts. Creating the automation scripts for test flows. Analyzing the results of execution & fixing the scripts/data.
• Used QTP 6.5 to conduct data-driven testing by pulling data from a table.
• Workied on major applications like
• SEP (Simplified Enrollment Project) - CSR, Single Sign-On (SSO) & MQ interfaces.
• Chase Bill Management Center (CBMC)
• ATM PIN PW RESET

Tools: Used: QTP 6.5, JSP, Java, Test Director 8.0, Oracle, Windows NT/2000, VSS