Validation Lead Resume

PROFESSIONAL SUMMARY:

13 years of experience in Quality Assurance in various capacities in the role of Validation Lead, Sr. Validation Engineer, QA Coordinator/ Engineer
Validation Lead in Pharmaceutical/Medical Devices Industry; involved in testing of eCOA (Clinical outcome assessments), Confidential (Patient Reported outcome) and EDC (Electronic Data Capture) systems
Solid understanding of 21 CFR Part 11, GCP guidelines and regulations
Extensive knowledge in configuring and usage of Mobile (SITEPad, LogPad, SITEpro, DIARYpro) and Medical devices (Master Scope, ECG); data transfer, analysis and data correction/coordination of clinical data from the devices
Expertise in Preparing effort estimation, Requirement Analysis, Gap Analysis, Business Impact analysis, High level design, Schedule and task tracking, Problem analysis, Validation Protocol/Plan, Test Strategy, Test cases (IQ, OQ, PQ), Test Reports, Requirements Traceability document, Summary Report, SOPs and Training manuals, Reviews, Business support, Status reporting and Knowledge Management
Experience in Manual, Automated Functional Testing (using Win Runner and Quick Test Professional), Automated Load Test Tool and monitoring tool (Load Runner and Sitescope)
Win Runner, QTP Test Automation includes Test Automation script development, Test Automation framework development, Functionality & Regression Testing
Proven success in scripting different applications (Web, Web service and ERP) with Automated Test Tools and perform Load, Stress, Endurance and Capacity testing and server utilization analysis
Have extensively used Test Director/Quality Center for managing the Test Requirements, Test Plan, Test execution and Defect Tracking
Experience working in SDLC and Agile Methodology; managing offshore team

TECHNICAL SKILLS:

Test Analysis: Functional Requirement Gathering & Analysis, Analyzing Business Rules, Test Flows, Test Planning, Test Case creation (IQ, OQ, PQ), Test Reports, Traceability document, Defect Tracking & closure, System Change Request, Impact Analysis

Test Management: Test Director, Quality Center

Mercury Interactive: QuickTestPro, Quality Center, Test Director, LoadRunner, WinRunner

Bug Reporting: JIRA, TestDirector, Quality Center, Bugzilla

Medical Device: SITEPad, LogPad, SITEpro, DIARYpro, ECG, WAMPC, Master Scope

Reporting Tools: Cognos, Business Objects

Analytics Tool: Tableau

Webservice testing: SOAPUI, Postman

Monitoring Tools: Sitescope, Perfmon

Databases: Oracle and MS Access

Web Development: HTML, XML, VBScript

ERP: PeopleSoft HR 8.8 (eRecruit, ePerformance and eCompensation), Finance 8.8 (Accounts Payable, Asset Management, General Ledger, Procurement, eExpense, Purchasing and eProcurement)

PROFESSIONAL EXPERIENCE:

Confidential

Validation Lead

Responsibilities:

Responsible for planning, monitoring, and control of the testing activities for multiple applications
Create/maintain Test Strategies and Test Plans according to Test Objectives and Organizational Test policies
Lead, guide and monitor the analysis, design, implementation and execution of the test cases, test procedures and test suites based upon requirements
Create/maintain various testing artifacts and testing reports during the lifecycle of the project
Hold and facilitate test plan/case reviews with cross - functional team members
Oversee Software Verification Testing performed by assigned team members, to ensure timelines are maintained and quality documentation are developed
Conduct functional, data accuracy and security/role-based testing of Web-based and mobile applications
Train/manage and work closely with onsite and overseas SQE teams, monitor testing efforts and ensure defects are addressed prior to release
Validation of Site Performance Analytics using Tableau; Validation of Extraction, Audit, Session, Reminder, missed visit reports using Cognos
Automate the test scripts for GUI, Functional, Data-Driven and Regression testing using QTP
Involve in Requirements Gathering, Requirement Analysis, Scenario Identification, Test Planning of Performance testing. Complete Performance Qualification (PQ) by creating Load test scenarios, executing the same and analyze the results using LoadRunner Analysis module and publish reports
Conduct and/or actively participate in meetings related to the multiple project/s, with clients and/or other contractors
Provide support / consultation for a successful UAT.
Create and maintain Requirement Traceability Matrix (RTM) and ensure complete test coverage
Assist in the development/review of standard operating procedures related to the development, configuration, evaluation, implementation, and testing of systems
Advise and recommend organizational testing strategies, processes and methodologies
Share best practices, lessons learned and knowledge with the rest of the team

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