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Validation Lead (onsite) Resume

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

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