Validation Lead Resume
PROFESSIONAL SUMMARY:
Efficient Test Engineer with 8 years of experience and solid knowledge in software testing, extensive experience in software development lifecycle methodologies including both Agile and Waterfall models, Quality management, Process - Quality and Compliance. Adept at Creating test design, test scripts and test report, Traceability Matrix, Defect tracking, Metrics reporting and Test management.
CORE COMPETENCIES:
- Software Testing Life Cycle
- Quality Management
- Waterfall and Agile Methodologies
- Authoring/Review of Test Design, Test Cases, Test Report, Requirement Traceability Matrix
- UI & Compatibility Testing
- XML Generation Testing
- Regression & User Acceptance Testing
- Data Interface & Migration Testing
- Performance Testing
- Web-Based Application Testing
- Defect Tracking
- QA & QC Standards
- Team Management
- and Mentor Skills
TECHNICAL SKILLS:
Testing Skills: Agile Testing, Manual Testing, IVR Testing, Mobile Testing, Performance Testing, Database Testing, Functional Testing, Documentum Testing, User Acceptance Testing, API Testing
Architecture: Client server, web based and mobile applications
Database Knowledge: SQL server 2005, SQL server 2008
Environment: Windows XP, Windows Vista, MAC OS
FDA Regulations / Validation Protocols: 21CFR Part 11, 210/ 211, 810, 820, GxP (GMP, GCP, GLP), URS, FRS, RTM, IQ, OQ, PQ, SOPs.
PROFESSIONAL EXPERIENCE:
Confidential
Validation Lead
Responsibilities:
- Estimate, prioritize, plan, and coordinate testing activities
- Lead the development of the testing framework
- Develop end to end test strategy
- Author and Review test design, test cases and test report
- Involve in Functional, Regression and Risk Based Testing
- Interact with customer to support User Acceptance testing, provide Test and Defect Metrics on biweekly basis
- Create traceability Matrix to ensure that the test cases, test plans are detailed and defects are thoroughly identified and linked to the requirements
- Develop and implement software/systems testing standards and procedures, and oversees testing
- Document and analyze test results, and makes recommendations to improve overall quality
- Provide/Review CAPA and RCA of UAT and Post-Production Defects and report to test managers and Client
- Collaborate with testers, developers and business users in testing complex projects and in the overall enhancement of software product quality
- Mentor and educate testers on testing and documentation practices with SOPs and Best Practices documents
- Report to top management on the performance of the Quality Management System and any need for improvement. Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources like score cards, Key Performance Index
- SLAs and KPIs reporting and monitoring, Risk Management
- Involve in Process and Assurance Audits with Delivery Excellence Team, providing CAPA for the observations and timely closure of the same
- As a Compliance lead, involve in ensuring 100 % compliance in the deliverables, s and project activities
Confidential
Test Lead
Responsibilities:
- Submitting Monthly Metrics to the client
- Submitting RCA for System defects, UAT defects and Post Production defects on Monthly/Release basis
- Submitting Weekly Status Report and monthly status report for all the portfolios.
- Involved in automation proposals and feasibility part in the project - Work Soft Certify
- Involved in Mobile Testing for all the projects
- Involved in Browser compatibility testing
- Involved in Agile Testing
- Involved in requirement and estimation calls, scrum calls with client for every sprint across brands as test lead
- Involved in estimations for every release as per requirements
- Participated in the Requirement session and understanding functionality.
- Execution and Peer reviewing of test cases
- Performed Functional testing and Sanity Testing
- Defect Tracking and Reporting
- Mentoring the resources based on their goals
Confidential
QA Tester and Module Lead
Responsibilities:
- Prepared Test Cases based on Functional specifications
- Participated in the Requirement session and understanding functionality
- Execution and Peer reviewing of test cases
- Performed Functional testing, Regression and performance testing
- Defect Tracking and Reporting
- Supporting the team members in Testing
Confidential
QA Tester
Responsibilities:
- Ensure the correct functioning of clinical trial software with focus on patient safety and integrity of clinical study data
- Ensure all activities and deliverables comply with FDA regulations
- Ensure that requirements are clear, testable, and consistent with the clinical trial protocol
- Develop validation plans according to a risk-based testing methodology
- Design test plans
- Generate and execute test scripts
- IVR Testing
- Document defects and track resolution
- Leading a team of three which is responsible for the end to end testing activities and materialize a clinical protocol
- Preparing Sign-Off document, Test Summary report, Test Case Matrix document and UAT release document.
- Involved in new members on validation testing and the product