SUMMARY

• 14 plus years of experience in IT as Validation and Quality Assurance - tester, technical analyst, test lead and test manager
• 12plus years of experience in Life Science - Pharmaceutical projects domain working with clients including Confidential Pharmaceuticals, Confidential Technologies, Confidential, Abbott and Confidential
• Extensive experience in handling Clinical, Regulatory, Operations, Commercial, Medical, and Quality applications in Life sciences industry
• Expertise in Project planning, Estimation, Validation Plan, Test approach, Test script creation, Dry run and Test execution, Test summary, Defect Tracking, RTM and Metrics reporting
• Expertise in regulatory guidelines including 21 CFR part 11 and 21 CFR part 820
• Expertise in end-to-end testing including HW IQ, SW IQ, OQ, PQ, UAT and Post production testing
• Comprehensive knowledge of the methods, techniques, and process of system validation and verification
• Excellent understanding of Waterfall and Agile methodologies
• Experience in managing projects from the customer location.
• Good understanding of the life sciences industry standards including SOPs, GDP, GLP and GMP
• Experience in Data migration and Disaster Recovery testing
• Has supported multiple projects in UAT
• Expertise in Requirement Analysis and Risk Assessment
• Experience on tools like HP Quality Center/ALM, Toad, VSS,and knowledge in QTP and Load Runner
• Good experience in testing and handling GxP and non GxP applications
• Experienced in SOX Audit testing and facilitating KPMG Audit
• Experience in validating various COTS product including TrackWise, SAM Track and Inform.
• Experience validating integrated system with more than two COTS product.
• Experience in coordinating with vendors for defect fixing and implementation
• Coordination with business teams for requirement understanding, clarifications, status reporting and project planning
• Over 8 years of experience in leading and managing a team of 20+ members
• Handling and leading multiple testing projects at onsite and offshore
• Hands on experience on Stored Procedures (SP) using PL/SQL
• Excellent Analytical, client interfacing and team handling skills

TECHNICAL SKILLS

Testing Tools/Frameworks: HP ALM 12.5, Quality Center, Quick Test Professional (knowledge)

Operating Systems/Languages: Windows 10/7/XP/Vista/2008, iOS 4 & 6, SQL, Java, VB

Database: Oracle 8i/9i/10g,SQL Server 13.0

Documentation Tools: MS-Office, MS-Visio, MS Project Plan

Web Technologies: HTML, XML

Other Tools: VSS, Trial Track, Toad

PROFESSIONAL EXPERIENCE

Confidential, Branchburg, NJ

Validation Risk Analyst

Responsibilities:

• Coordinate with Business Unit to ensure all requirements are covered in RS.
• Review Requirement Specification, Functional Specification. Test Plan, Test Case in ALM, Summary Report and other SDLC oriented documents.
• Prepare Quality Assurance Plan (QAP) and Quality Assurance Summary Report (QASR) for every workstream.
• Verify if the integration of COTS systems follows validation protocol.
• Perform Risk Analysis involved in each workstream within project
• Lead and coordinate UAT.
• Coordinate and follow up activities between Vendor and Business Unit.
• Conduct Gate reviews at the end of each SDLC phase.
• Ensure compliance is followed.

Confidential, Seattle, WA 

Test Engineer

Responsibilities:

• Understand new Medical Tools
• Write Validation Plan for several Medical tools and prepare a high-level User Requirements document
• Write Validation Protocols and execute the test results and prepare Validation Reports
• Facilitate PreMarket Approval (PMS) submissions
• Implement the understanding of FDA 21 CFR Part 814 and 820
• Perform testing on Medical devices/ tools
• Accountable for driving all testing efforts, issues, escalations to a closure
• Responsible for planning for Test Execution activities by assigning tasks on daily/weekly basis
• Created strategies, managed and organized large scale projects across multiple teams
• Track defects during testing in TFS
• Manage creating, modifying and routing documents for approval in Electronic Document Management System such as EDMC
• Responsible in developing Computer Systems Validation Methodology, following FDA Regulations (21 CFR Part 11 and 21 CFR 820) and GAMP 5, such as Standard Operating Procedures, Validation Master Plan, templates and trainings.

Confidential

Validation Specialist

Responsibilities:

• Provide Project estimation, proposal and inputs on project plan
• Handle resourcing, Status reporting, project delivery and escalations
• Requirement Analysis, support in Validation Risk Assessment
• Ensure test cases are updated in HP ALM
• Prepare / review Validation plan, Test approach, test case, test summary, defects, RTM and test memo
• Create and execute System test scripts, IQ, OQ, PQ and UAT
• Ensure GDP and 21 CFR part 11 compliance
• Perform Regression, UAT testing, BAU and post production testing
• Analyze RFCs for testing scope
• Coordinate document approvals, sign-offs and archival
• Coordinate with vendor on clarification and defect fixes

Confidential, IL

Validation Lead

Responsibilities:

• Handle the Test Protocols for a new version of the application - CMS Next under ADD
• Estimate and propose automation
• Prepare test case and perform testing using HP ALM
• Responsible for planning for Test Execution activities by assigning tasks on daily/weekly basis
• Present Weekly, Monthly and Annual status reports and metrics
• Provide inputs / guidance to the project team on critical issues
• Ensure GDP is followed and responsible for defining process improvements including guidelines, templates etc.
• Follow 21 CFR Part 11 compliance in all Testing Activities
• Track wise Testing - Addition of new workflows to Track wise application
• Performed OQ testing on SAP Work Streams
• Conduct weekly team meetings with the team
• Handle resourcing, project delivery and escalations
• Provide inputs for testing related SOPs
• Interact with offshore counterparts for smooth project execution
• Conduct internal Audits and Assist in FDA / regulatory Audits as required
• Coordinate with vendors for major implementations
• Review critical deliverables
• Create / revise SOWs as required

Confidential, DE

SAL (Service Application Lead)

Responsibilities:

• Handle maintenance, testing and implementation activities.
• Review documentations and other critical deliverables to clients.
• Train new resources on the application and project related activities.
• Facilitate audit.
• Responsible to support OPAL related queries, data collection, interface related and Service Introduction activities.
• Working with Business in defining the scope, handling change controls and end delivery.
• Identify project risks, analyze and in corporate remediation steps.
• Provide Project estimation, proposal and inputs on project plan
• Present weekly, monthly status report to client

Confidential

Validation Test Lead

Responsibilities:

• Lead the onsite and offshore validation team
• Conduct meetings with Change Control Board members to approve change releases.
• Create, execute, review and approve validation deliverables (such as Validation Plans, Test Plans, Test Scripts, Reports, and other supporting documentation)
• Administer the server for Mercury Quality Center, create and maintain new projects in Quality Center.
• Onsite Test Lead and coordination of testing activities with offshore.
• Perform SAP testing in both functional and technical areas.
• Create manual test scripts for the Change Requests of Non-SAP applications.
• Create automated test scripts for regression testing of TDMS application, execute functional test scripts for the Non-SAP application patches, review pre-execution test scripts and post-execution test scripts of SAP application and review Change Control Forms.
• Perform System and regression testing
• Attend status calls with the project management team to update on the progress of the project
• Communicating with the Business and the Application Team to understand the requirements
• Getting clarifications addressed from the client
• Create and execute test scripts for QA TrackWise
• Responsible for on time deliverable
• Attend client meetings
• Reviewing Test Scripts based on GxP standards
• Preparing Summary report and Sign off documents
• Perform SOX Audit for various applications and facilitate KPMG Audit
• Test management activities, project tracking, status updates.

Confidential

Quality Analyst

Responsibilities:

• Prepare estimation, perform testing and technical reviews.
• Handle daily deliverables and its issues.
• Send status report on weekly basis.
• One point contact and support for Audit and training related activities.
• Validate TrackWise application
• Create and execute OQ
• Create Test summary and Traceability matrix
• Implement Fast track and Fast forward trials using dump (IQ)
• Analyze user and functional speculations
• Track defects in Trial track and participate in defect review meetings
• Train new team members in Inform product and testing
• Track and maintain documents in VSS
• Review executed test scripts
• Coordinate with onsite leads for clarifications and status
• Manage work allocations
• Lead 25-member testing team
• Create metrics and track on time deliverables