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Validation, LeaD
SUMMARY
- Seasoned, self - driven, detail oriented Computer Systems Validation Specialist with 14 years’ experience in Software Quality Assurance with diversified skillset covering Computer Systems Validation, Agile - Scrum, Project Management, Web Services and Mobility across Life Sciences (Pharma), eCommerce and Retail domains.
TECHNICAL SKILLS
- Computer Systems Validation (CSV)
- GAMP 5
- Mobility Test Lead
- Validation Lead
- Agile - Scrum
- Web Services Testing
- 21 CFR Part 11
- Scrum Master
- SQL
- GxP Systems
- QTP
- ISTQB Certified
- Life Sciences (Pharma)
- JIRA
- POSTMAN
- HP ALM
- Rally
- SOAP UI
PROFESSIONAL EXPERIENCE
Confidential
Validation Lead
Responsibilities:
- Analyze and develop new Software Lifecycle templates for User Requirements Specifications, Project Plan, Test Plan, Validation Plan, Combination Project/Validation Plan, Combination Project/Test Plan, Functional Requirements Specification, Traceability Matrix, User Acceptance Test,Project Summary and Project Release Notes for Managed Services Team.
- Optimize deliverables and handle milestones for Managed Services pilot and Outside US rollout.
- Organize Review Board meetings connecting the Quality Assurance Review Board with multiple project teams, counseled and enabled the project teams to determine the right classification of the system.
Confidential
Validation Lead
Responsibilities:
- Authored, collaborated, reviewed and delivered key Computer Systems Validation deliverables like Change Request, User Requirements Specification (URS), Project/Validation Plan, Functional Requirements Specification (FRS), Validation, System & Regression Test Protocols, Traceability Matrix, Security Testing Summary, UAT, Project Release Notes and Validation/Project Summary. Ensured the deliverables meet the Regulatory requirements for GxP systems including 21 CFR Part 11.
- Achieved effective Risk Assessment of the systems by conducting FMEA with Quality Assurance team and other project stake holders.
- Coordinated with business users, conducted UAT, signed off and certified the applications to deploy in production.
- Participated in Corrective Action and Preventive Action (CAPA) meetings about non-compliance or potential non-compliance of IT Systems.
- Directed successful Validation Testing strategy by following GAMP 5 guidance and ensured quality deliverables from the project teams.
- Challenged and ensured systems meet the specified Performance Qualification criteria to perform as intended in production.
- Certified the latest test version of the app on mobile devices (iOS & Android) by performing compatibility testing with various devices and assessed the app’s behavior under various interruptions: incoming calls, SMS, video calls.
- Designed, developed, implemented and automated web services testing procedures and verified the database using SQL.
Confidential
Validation Analyst
Responsibilities:
- Authored, reviewed, owned and delivered key Validation Testing deliverables like Validation Plan, Validation, System & Regression Test Protocols, Traceability Matrix and Validation/Project Summary.
- Expedited testing and project timelines by conducting effective Requirements, Design and Code reviews and eliciting defects early in the cycle.
- Identified the automation candidates and built the automated test suite using QTP.
- Streamlined processes by scheduling discussions across multiple stakeholders involved in the projects to help clients Run Better.
- Averted project risks pro-actively by apprising clients & advocating necessary risk aversion measures up front.
- Executed Validation Protocols and triaged failures with Business Analyst and development team and brought them to closure.
- Spearheaded teams, resolved conflicts and optimized resources and responsibilities between onsite and offshore teams.
Confidential, Atlanta, GA
Scrum Master, Project Lead
Responsibilities:
- Recommended Agile - Scrum methodology, assembled an Agile - Scrum team of 14 as Scrum Master and delivered multiple sprints across various projects successfully.
- Paired with Mobile Centre of Excellence team, enriched project team’s knowledge and enabled the team to use multiple solution accelerators for different aspects of mobile testing.
- Handled native & web apps testing on various mobile devices and guided the team in other mobility specific testing area like analytics using User Agents.
- Steered estimates, directed teams and handled resource planning for multiple projects running in different release schedules.
- Computed multiple project metrics and summarized key metrics to the Senior Management.
Confidential
Scrum Master, Senior Test Lead
Responsibilities:
- Orchestrated an Agile - Scrum team as Scrum Master for multiple projects in QA team, conducted Sprint Planning, Stand Up & Retrospection meetings and delivered sprints successfully on time.
- Spearheaded project status review meetings across multiple projects and apprised the management about the status of each of the projects.
- Identified the automation candidates and built the automated test suite using SILK Test tool.
Confidential, San Jose, CA
Test Lead, Software Development Engineer Test
Responsibilities:
- Achieved Shift left by participating in Design & Code Reviews by eliminating defects earlier in the cycle.
- Identified, analyzed, defined and documented Business Processes, Use Case Scenarios and FSD (Feature Specification Document).
- Authored, reviewed, collaborated and delivered key Functional Testing deliverables like test plan, test scenarios and test cases developed by the team.
- Evaluated, authored and assembled an automation framework and further identified the automation candidates and built the automated test suite using SILK Test tool.
- Analyzed and triaged failures with Project Manager, Business Analyst and development team.
Confidential
Software Development Engineer Test
Responsibilities:
- Developed and implemented test plan and scenarios.
- Presented key inputs and worked with business teams in defining system requirements.
- Flashed Personal Digital Assistance (PDA) devices with new builds & executed the functional test cases.
- Developed and automated regression test suite using Confidential ’s in-house tool Windows Tools Technologies.
- Reported the test results using a tool called “Tactics” and tracked bugs using a tool called “Product Studio”.
