PROFILE:

• Over 5 years of diversified experience in teh field of Quality Assurance /Software testing wif exposure of both Manual and Automated Testing of stand alone, client/server and web applications.
• Highly skilled Software Engineer wif seven years of significant and progressive experience in Computerized Systems Validation, Automation and Quality Assurance in teh Biotechnology/Pharmaceutical and Medical Device industry, wif a solid background in Laboratory Equipment, Manufacturing Equipment, Medical Device Validation, Verification and Information Technology.
• Knowledge of SDLC and its phases.
• Experience of using manual test scripts to test and validate pharmaceutical applications in teh event of a d Confidential center failure/recovery.
• Very strong to Performing functional, application, regression and performance Testing and Analyzing test results, requirement documents to ensure functionality also involved in Analyzing d Confidential base results.
• Experience of testing regulations in particular 21 CFR Part 11(FDA regulations for electronic signatures).
• Strong experience wif FDA regulated environments under 21 CFR Part 11, 210, 211 and 820 proficiency in Quality Systems, Computer Systems Validation regulations; ISO 9001:2000, 16949, 13485.
• Proficient wif System Protocols and Validation Protocols (IQ/OQ/PQ) for Software Validation, Laboratory Equipment Validation, Computerized System Validation, Bioprocess Systems, SCADA Systems, PLC, DCS Systems, Automation and LIMS.
• Proficient in analyzing Business Requirement and Functional Requirement Specification Documents and expertise in developing test Plan.
• Experience in designing, developing and executing test cases, test scripts and test strategies.
• Performed extensive Backend Testing of d Confidential validation of applications using SQL queries.
• Executed SQL statements to check if teh d Confidential integrity TEMPhas been maintained.
• Experience in different types of testing such as integration testing, regression testing, system testing and UAT.
• Extensive knowledge of SDLC (Software Development Life Cycle) such as Waterfall, Agile and Spiral.
• Profound understanding of insurance policies like HMO and PPO.
• Experience wif HIPAA 4010/5010 versions and EDI transaction codes such as 270/271(inquire/response health care benefits), 834(Benefit enrollment), 835(Payment/remittance advice), 837(Health care claim), 276/277(Claim status).
• Knowledge of workingwif x12 format.
• Tracked and reported bugs using Quality Center.
• Wrote complex SQL queries to perform teh backend testing using Toad.
• Executed SQL statements to test teh integration between application and d Confidential base.
• Maintained Test Matrix and Requirement Traceability Matrix.
• Proficient in performing functional and d Confidential driven testing using QTP

TECHNICAL SKILLS:

Testing Tools: QTP (Quick Test Pro)

Bug Reporting Tool: Quality Center, Bugzilla, Jira

D Confidential bases: Oracle, MS SQL Server, MS Access, DB2

Language: Java, Visual Basic, HTML, XML,C#,C++

Operating systems: Windows XP/7/Vista, UNIX, LINUX

WORK EXPERIENCE:

Confidential

QA Engineer

Responsibilities:

• As a key member of teh QA team, me was responsible for creating teh test plan, high level test case documentation & complete End to End testing. Was involved in teh creation of both teh Shell test cases and teh Site specific test cases.
• Created and maintained teh 21 CFR Part 11 Assessment.
• Coordinated wif System Analyst to make teh Server and Machines qualified through complete IQ/OQ procedures. performed full Validation life cycle, SDLC (UR, FS, DS, IQ, OQ, PQ), deviations, change control requests, Validation report and Medical Device risk assessment
• Involved in software testing wif teh ability to follow written procedures.
• Assists in building audit trail of DR activities, deliverables and traceability for projects.
• Review computerized systems Validation documents such as: Requirements Specification Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, and D Confidential Migration Plan. Pre/Post Executed Test Scripts. Traceability Matrix. Release to Production Statements.
• Apply FDA, MHRA, and other applicable global regulations to teh development of computer systems supporting regulated business processes.
• Follow SOPs and industry best practices.
• Maintain close communication wif stakeholders and team members to keep apprised of computerized system needs, impacts on computer Validation, project Validation status, and other relevant issues.
• Assist in planning, implementing, and documenting user acceptance testing.
• Direct and review testing.
• Provide guidance on quality issues that affect teh integrity of teh d Confidential or teh system.
• Prepare Validation summary and test summary reports.
• Facilitate teh Computer system Validation Risk Assessment to identify governing regulations and Validation deliverables during teh development of teh computer system.
• Review Validation deliverables for projects which are contracted to third party suppliers.
• Obtain and respond to QA review.
• Participate in establishing standard quality and Validation practices.
• Independently assess compliance practices and recommend corrective actions.
• Approve validated computer system related change requests.
• Monitor regulatory and inspection trends and advice teh business on suitable action.
• Performed Validation testing on teh application in accordance wif 21 CFR Part 11.
• Developed Traceability Matrix to track requirements during teh QA Testing Phase.
• Maintained teh Requirements Traceability Matrix (RTM).
• Involved in gap analysis to find teh gap between functionality offered by Oracle Clinical and our business requirements.
• Implemented c GLP and c GMP during teh testing of Oracle Clinical
• Was involved in teh automation of business critical test cases using QTP and Quality center to perform functional testing
• Was responsible for automating all teh business critical scenarios wifin a period of 7 weeks using QTP and QC business process testing.

Environment: Windows UNIX, Quick Test Professional, Maximo, Waters Empower, LIMS (Watson, Lab ware, Quality Center, Peregrine, Solution Tracking System, MS Project Manual Testing

Confidential

QA Analyst

Responsibilities:

• Involved in writing Test Plan and making sure that teh development of test plan is according to teh requirements.
• Involved in Back End Testing by extracting flat files from teh server, which were generated by a Batch process to verify d Confidential against expected results
• Reviewed test assignments, developed test plans and scripts, and conducted test as assigned.
• Used Microsoft excels to write test case and exported to Rational Clear Quest.
• ValidateEDI Claim Process according to HIPAA compliance.
• Involved in testing HIPAA D Confidential base, which incorporates all teh HIPAA (Health Insurance Portability and Accountability Act) transaction sets.
• Validated teh translated HIPAA files wif teh proprietary CCR (Common Claim Record) implementations.
• Tested d Confidential to check HIPAA - eligible & participation check for individual coverage.
• Involved in creating test scripts and test d Confidential files for teh HIPAA transaction based on teh ANSI X12N HIPAA standards.
• Performed Functional testing using QTP.
• Used Visual Basic for ASP.NET debugging and White box testing.
• Inserted various check point using QTP, to measure teh performance.
• Conducted result analysis and interacted wif developers to resolve bugs.
• Assisted in UAT (User acceptance testing) testing.
• Performed regression, system testing and end-to-end testing of teh application.
• Involved in GUI and functional testing of teh application.
• Created Complex SQL Scripts and embedded them into Unix Shell Scripts to perform teh back end testing.
• Tested and validated teh d Confidential base tables using SQL queries and Stored Procedures and performed D Confidential Validation and D Confidential Integration.
• Track and managed bug using Clear Quest.
• Participated in Status Review Meetings.

Environment: HIPAA, EDI, QTP,SOAPUI, Rational Clear Quest, SQL, GUI, Oracle, HTML, XML, Java, WINDOWS XP, Oracle, UNIX, Apache.

Confidential

QA Tester

Responsibilities:

• Analyzed system test requirements and functional specification, involved in preparing Test Plans and Test cases and managed them using Quality Center.
• Performed Manual Testing and Involved in Functional, Positive, Negative Usability and Regression Testing for UAT (User Acceptance Testing).
• Performed backend testing by inserting d Confidential base checkpoints.
• Preparing defect reports and interacted wif developers for debugging of teh system Functionalities
• Preparing weekly status reports on teh progress for management reviews.
• Tested and validated functionality of new screens for customized applications.
• Responsible for weekly status updates showing teh progress of teh automation testing efforts and open issues to be resolved.
• Performed GAP Analysis.
• Performed extensive manual testing before doing teh automation.
• Involved in Functional, Integration and Regression Testing.
• Used SQL to query teh d Confidential base for D Confidential validation.
• Used Quality Center to log defects and monitored teh defects for successful resolution.
• Documented teh complete test process and results wif screen shots and Excel spreadsheets.
• Executed test cases and verified teh actual results against expected results.
• Generated weekly status reports to teh team manager and attend teh weekly status meeting wif Technical team, Team managers, and Business analysts.

Environment: Java, J2EE, Quick Test Professional 9.0, Mercury Quality Center