Software Quality Assurance, All Levels – India, USA

Strong experience in overall planning of Test Cycle including Requirement analysis, test planning, formulate test strategies, approaches, test specifications, test automation, test execution, traceability matrix and test status reporting with accountable for all testing deliverables.
Expertise in Computer System Validation
Experience in preparing and executing Validation protocols OQ/PQ.
Adept in preparing Validation Plan, Test Specification, Traceability Matrix, Test Metrics, Validation report, Client workflow documents, Test Summary report, User guides, Release note, IQ/OQ/PQ.
Validated softwares to fulfill requirements according to FDA guidance, 21CFR, GxP and HIPAA regulations.
Good Knowledge on GAMP, ICH, ISO, CMMi and Six Sigma.
Experience in Data Migration and Database testing using T-SQL queries.
Experience in streamlining QA processes and carrying out Risk Analysis.
Vendor audits to ensure that the solutions being implemented conform to regulatory standards and internal processes being followed
Experience in preparing and updating SOP and Validation artifacts Templates.
Experience in Requirement gathering, Gap analysis, developing requirement specification documents, estimating and analyzing testing approach, resources and giving trainings/demos to end users.
Exposure in preparing SOW (statement of work) and responding to RFPs (request for proposal).
Experience in Universe designing, developing and generating Reports, along with User
Acceptance Test and data accuracy test.
Experienced in interacting with business users to analyze the business process and requirements and transforming requirements into application, documenting and rolling out the deliverables.
An enthusiastic and project-oriented team player with solid communication and leadership skills and the ability to develop creative solutions for challenging client needs.
Expertise in different kind of testings like Sanity, Functional, Retesting, Regression, Benchmark, Installation, Exploratory testing, Migration testing and SQL query testing.
Extensive experience in testing of applications on diverse technologies like Web applications (Java/JSP/Silverlight/HTML/CSS/XML), Windows/Desktop based application.
Rich experience in QA testing methodologies (Waterfall & Agile Scrum) and have in-depth knowledge on all phases of SDLC and STLC
Proven track record in defect discovery and expertise in defect management tools Working in conjunction with the Stakeholders & Team to ensure adherence to sprint/project deliverables & timelines within budget & resource