EXPERIENCE SUMMARY:

• Confidential has more than 14 years of experience in Life Sciences domain.
• He has excellent skills in Computer System Validation, Business Analysis, Functional Testing, Database Testing, Compliance and Team management.
• He has sound knowledge and real - time experience on different software development life cycles that helped team to deliver critical application solutions to meet client expectation
• Working to maintain GxP compliance for FDA regulated environment. Computer Systems Validation (CSV), 21 CFR Part 11, GDP and in authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS) review and Functional Requirement Specifications (FRS) review and Requirement Trace Matrix (RTM)
• Review and approve Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Data Migration Protocols (DMP) and Validation / System Test Scripts.
• Define end to end SDLC validation methodology for computer systems based on regulatory & IT risk profiling. Expertise in GxP and 21CFR and its implications in computer system validation.
• Good understanding on the Life Cycle of QA process in the validated environments and Proficient in Validation testing, Configuration Testing, Functionality testing, Database testing and Regression testing for various builds/ versions.
• Proven experience designing and implementing testing strategies, formal test plans and test cases to ensure the delivery of quality software applications
• Involved in Audit preparation and ensures smooth audit completion and take necessary Corrective & Preventive Actions based on Audit findings
• Engaged with project teams to identify Quality, Compliance issues, provide CAPA and track it down for closure.
• Good Experience in Informatica - Information Life Cycle Management Data Archiving, Informatica Data Validation Option tool and Dynamic Data Masking
• Good experience in creation of templates, Power Form links and Validation in DocuSign application.
• Experience in API testing, Web Services, REST API using UFT and Post Man
• Good experience HP Quality center, in Requirements, Test Plan, Test Lab and Defects Modules.
• Strong project management experience in defining and initiating projects, assign testers, scheduling tasks and monitoring performance of component projects to ensure the ultimate success and acceptance of the program.
• Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards.
• Work with leadership team for Forecasting, Utilization, Client Profit, and articulate test efficiencies and cost savings.

TECHNICAL SKILLS:

IT Quality Compliance: 21 CFR Part 11, GAMP good practice guide, Risk Based Validation Internal Quality Audit, Validation Risk Assessment and Project Compliance health check monitoring

Testing: Manual, Validation, Dataware house, IT Quality and Compliance (Technical Assurance) and DB Testing

Tools: Used: InForm, Rave, Oracle IRT, Bugzilla, QC v.10 and DocuSign

Hardware / Platforms: Windows 98/XP/2000/Windows 7.

Databases: SQL Server & Oracle

Configuration Management Tools: MS Visual Source Safe, EDMS, First Doc 6.1, ServiceNow and Doc Compliance 4.01

Data warehousing Tool: Informatica Power Center Designer, Data Validation Option (DVO), Enterprise Data Manager (EDM) and Dynamic Data Masking tool Microstrategy 7.2.1, 7.2.3

PROFESSIONAL EXPERIENCE:

Confidential, Illinois

Validation Lead & Onsite Coordinator

Environment: Informatica Power Center Designer, Data Validation Option (DVO), Enterprise Data Manager (EDM),Dynamic Data Masking (DDM) and HP Quality Center

Responsibilities:

• Playing the role Validation Lead and Onsite Coordinator for testing team of 4 persons including mentoring, managing workload priorities, providing technical and functional knowledge.
• Authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS) review and Functional Requirement Specifications (FRS) review and Requirement Trace Matrix (RTM)
• Review and approve Validation / System Test protocols.
• Involved in writing, review and execution of Validation Protocols in HP Quality Center (QC).
• Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
• Maintaining all the Validation package documents in ADAM (Document Management System)
• Creation of DIET (Defects, Incidents, Enhancements Tracker) cases and track it till closure
• UAT Coordination with Business Users
• Performed Data Validation using Informatica Power Center Designer and Data Validation Option (DVO) for the systems Archived in StrEAM (Information Life Cycle Management).
• Verify the Legal Holds, Retention Policy and Data Masking using Informatica SQL Worksheet.
• Tracking the Defects in HP QC by Raising an IR and track it till close the issue.
• Sharing Weekly status Report with client on project status.
• Training the team members in the application and proctoring them.

Confidential, New Jersey

Validation Lead

Environment: Inform, Central Designer, First Doc, Quality Center v.10 and ALM v.11

Responsibilities:

• Follow Confidential 's Validation Process Create/Review/Approve Validation documents from Initiative through Certification Summary (including but not limited to: Initiative, Project Plan, Val Plan, Protocols, Trace Matrix, ISSD, Cert Summary, Test Plan, Test Summary, IR, Release Notes)
• Provide an independent review of the project deliverables to ensure they meet regulatory expectations and standards and provide approval to designated deliverables
• Ensuring deliverable are meeting quality gate requirements, thereby ensuring sequential execution of SDLC processes.
• Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
• Review and approve Validation / System Test protocols in HP Quality Center (QC).
• Participate in requirements walkthrough
• Maintaining all the Validation package documents in First Doc (Document Management System)
• Provide technical input in determining strategy for validation activities
• UAT Coordination with Business Users
• Lead the IR process until all issues are resolved and documentation complete
• Manage external contractors, and third party vendors for validation projects
• Provided inputs to arrive at an end-to-end test strategy for several large programs that connect multiple systems across divisions.
• Suggesting and contributing for process improvements as appropriate

Confidential

QA Lead

Environment: IRT (Interactive Response Technology), SQL Server 2008 and Bugzilla

Responsibilities:

• Played the role of Offshore Test Lead in a team of 1 Onsite and 20 Offshore team members
• Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards. Effort Estimation and team management
• Define and track quality assurance metrics such as defects, defect counts, test results, and test status
• Lead and conduct application regression scripts to be executed and identifying post-production defects
• Provide knowledge transition to the team and allocate the tasks
• Prepare Validation / Test plan and followed the timelines to complete each release of IRT projects
• Reviewed the Test Deliverables of the team and delivered quality products
• Monitor and control the test progress in line with the Test Plan
• Coordinate telecalls, attended daily status calls with Deliveries and Business Analyst
• Worked with senior management by involving new project proposals and estimations
• Coordinate end-to-end testing with external channel/domain QA teams
• Ensure compliance with testing best practices and standards
• Involved in review, Pre-approval and Post approval for all the System test cases.
• Performed defect leakage and route cause analysis

Confidential, Maryland

Validation Engineer & Onsite Coordinator

Environment: DocCompliance 4.01

Responsibilities:

• Involved in writing, review, execution, proctor of IQ, OQ, PQ and Configuration Scripts.
• Involved in providing templates, routing protocols, and review and approve for specification documents.
• Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals.
• Maintaining all the Validation package documents in DocCompliance (Document Management System)
• Creation of (Defects, Incidents, Enhancements Tracker) cases and track it till closure
• UAT Coordination with Business Users
• Involved in preparing RTM for the project.
• Training the team members in DocCompliance 4.01.
• Ensures the project team follows the Computerized Systems Life Cycle Process and Computer System Validation process throughout the project life cycle.

Confidential

QA Lead

Environment: ASP, Inform 4.5 and SAS Data sets

Responsibilities:

• Played the role of Offshore Test Lead in a team of 1 Onsite and 18 Offshore team members
• Liaising with client as Offshore Delivery Lead. Oversees the delivery process, define and gather metrics, status reporting, managing resource load within project, ramp-up, train and deploy in production, adhering to organizational standards.Effort Estimation and team management
• Define and track quality assurance metrics such as defects, defect counts, test results, and test status
• Provide knowledge transition to the team and allocate the tasks
• Prepare Test plan and followed the timelines to complete each release of Clinical Trail projects
• Reviewed the Test Deliverables of the team and delivered quality products
• Monitor and control the test progress in line with the Test Plan
• Coordinate end-to-end testing with external channel/domain QA teams
• Ensure compliance with testing best practices and standards
• Coordinate telecalls, attended daily status calls with Deliveries and Business Analyst
• Collecting and Collating Metrics
• Performed defect leakage and route cause analysis

Confidential

Tester

Environment: ASP.net, SQL Server 2000, Microstrategy 7.1.6, 7.2.3

Responsibilities:

• Involved in Impact analysis, Coding/Fixing of migration defects, Unit testing, Sanity out of the box web, Regression Testing.
• Prepared the test cases based on Requirement.
• Identify various scenarios for functional and integration testing.
• Configuration Control via Visual Source Safe (VSS). - Use of VSS for indicating the completion of various stages in the project.
• Generated Bug Reports, Daily status Reports, weekly Reports.