SUMMARY

• 10 plus years of experience in IT as tester, technical analyst, test lead and test manager
• 8 plus years of experience in Life Science - Pharmaceutical projects domain working with clients including Confidential, Confidential and Abbott
• 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 GAMP
• 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 including Quality Center, 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 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: Quality Center, Quick Test Professional (knowledge)

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

Database: Oracle 8i/9i/10g,SQL Server 7.0

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

Web Technologies: HTML, XML

Other Tools: VSS, Trial Track, Toad

PROFESSIONAL EXPERIENCE

Confidential, IL

Validation Lead

Responsibilities:

• Handle the Test Protocols for a new version of the application - CMS Next under ADD.
• Estimate and propose automation.
• Present Weekly, Monthly and Annual status reports and metrics
• Provide inputs / guidance to the project team on critical issues
• Ensure GDP is followed
• Responsible for defining process improvements including guidelines, templates etc..
• Trackwise Testing - Addition of new workflows to Trackwise application
• 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 incorporate 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
• Follow 21 CFR Part 11 compliance in all Testing Activities
• 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

Confidential 

Developer

Responsibilities:

• Develop and debug Stored Procedures (SP) using PL/SQL
• Understand user requirements
• Analyze data for accuracy
• Report issues and coordinate with client
• Perform root cause analysis in case of incorrect data
• Troubleshoot issues with IBM team