16+ years of IT experience in Quality Assurance lead and as Business Analyst working with diversified industries, including Banking, Pharmaceutical, eCommerce, manufacturing etc. * Capable of managing QA Team * Experienced on Waterfall and AGILE methodology * Experienced on Mobile testing * Capable of adopting any business terminology in a short time of period * Mostly functional/Manual testing (black box) * Also ran automated scripts and analyzed the results * Technically resourceful in different types of testing such as Functional/Regression/ System/Integration / Volume / Load / Stress Testing * 6+ years of experience in FDA regulated environment. * Six years of experience working on eDC system (electronic data capture) such as Inform, RAVE * Did two assignments at Medidata (2005, 2006-7) testing their RAVE electronic clinical data management (eCDM) product to include CTMS and Electronic Data Capture (EDC). * Supported pharmaceutical clients as: PFIZER, AMGEN, PROPHARMA, KING, ENZON, ROCHE, J&J, Boston Scientific * Experienced mostly in manual and some automated testing using WinRunner, UFT, Quality Center (Test Director), HP ALM * Possess a good knowledge if STLC and SDLC * Possess QA Lead experience and excellent communication skills. * Experienced creating/maintaining heavy documentation including Developed Test plans from Business and Technical Specifications * Prepared Specification documents, Test Plans, Test Scripts, Summary Report * Experienced in Import / Export / Load data to Oracle database * Experienced in back end testing using SQL queries, generating reports to ensure data integrity and validate business rules * Experienced in Bug tracking, reporting and Test Report preparation * Knowledge and experienced in FDA and EMEA regulations especially 21 CFR Part 11 and Annex part 11, ICH E2B guidelines, GxP (GMP/GCP/GLP) guidelines, GAMP (GAMP5), Quality Assurance regulations, and Good Documentation and Good Testing Practices * Excellent interpersonal and communication skills with clear understanding of business and ability to work independently or as a team member. * Good team player, Quick learner

Highlights:

• Defect Tracking
• Integrate
• JIRA
• BASIC Programming Language
• Business Requirements
• Test
• Test Plans
• Visual Basic
• Agile Methodologies
• Agile methodology
• it jobs
• agile
• software
• Manual QA Lead
• Agile methodologes, Test Plans, Test, Business requirements, JIRA, Defect Tracking