Shalina Veliyathu Hameed

• Provided quality oversight for SaMD and GxP systems, actively managing the SDLC in adherence to regulatory requirements, industry standards and best practices
• Provided process guidance throughout SaMD design and development, ensuring compliance with ISO 13485, 21CFR 820, and ISO 14971
• Worked as part of Scrum/Kanban Agile teams in a multi-pod fast paced environment
• Actively participated in Risk Management, incorporating ISO 14971 principles and utilizing FMEA to identify, analyze, document, and mitigate risks
• Guided project teams in developing Software Development Plans/Validation plans, integrating quality practices and Agile methodologies into SDLC while maintaining regulatory compliance
• Reviewed, approved and maintained SaMD Design History File, including design input, design output, design verification and validation records, design changes, risk management documentation, and other relevant records in accordance with established Standard Operating Procedures (SOPs)
• Contributed to requirement refinement, ensuring accuracy, completeness, and testability through thorough review and feedback
• Actively engaged in design reviews, offering valuable insights and feedback at crucial milestones throughout the development life cycle
• Led teams in assessing systems for 21 CFR Part 11 and Annex 11 compliance
• Ensured data integrity and cybersecurity, overseeing technical controls and validating their effectiveness
• Implemented the innovative Computer Software Assurance (CSA) approach following GAMP 5 principles and a risk-based approach for validation
• Guided team in developing and executing IQ, OQ, and PQ protocols
• Led defect management for issue identification, tracking, and resolution
• Reviewed and approved key validation deliverables, including Validation Plan, Verification Plan, User and Functional Requirement Specification, IQ, OQ, PQ, IDP, Incident Report, Defect Report, Requirement Traceability Matrix, Release notes, and System Certification, aligning with SOPs and regulatory standards
• Reviewed Manual and Automation(Tosca) test cases
• Collaborated with the DevOps engineering team to integrate quality assurance activities into CI/CD workflow
• Example: Define test strategy, automate tests, continuous monitoring and analysis of results etc
• Certified Computer systems for production implementation
• Managed change control processes to assess and validate modifications to the software systems
• Provided audit support for internal and external audits
• Enabled continuous improvement through identification, investigation, and implementation of corrective and preventive actions (CAPA) for quality issues and non-conformances
• Worked with Leadership team to enhance software lifecycle processes and SOPs.

• Led validation efforts for multiple releases of Humira Complete Pro Project, following an Agile delivery approach, to ensuring compliance with regulatory requirements including 21 CFR Part 11, as well as adherence to AbbVie’s standard operating procedures
• Developed and executed validation plans, coordinated with cross-functional teams and managed project timelines and resources
• Authored, reviewed and approved validation documentation, including Change Requests, Validation plans, Requirement specifications, Test Protocols, Defects, Traceability Matrix and Test Summary Reports to ensure adherence to regulatory standards and guidelines
• Collaborated with subject matter experts to address compliance gaps, ensuring accuracy and completeness of documentation
• Worked closely with Business Systems Analysts (BSAs) to identify and address any gaps in system requirements, ensuring they are accurate, complete, and testable
• Conducted risk assessments to identify and prioritize validation activities based on criticality and impact
• Developed strategies to mitigate risks and ensure the reliability, integrity, and security of computer systems and processes
• Led validation testing activities, including test script development and execution, system and integration testing, and meeting validation requirements
• Managed test data, environments, and troubleshooting during testing
• Utilized Test Management Tools, such as Quality Center and ALM to streamline test management processes and to ensure traceability
• Managed change control processes for validated systems, evaluating change requests, performing impact assessments, and implementing validation activities for system changes/upgrades using tools ADAM, ServiceNow, and KNEAT
• Maintained validation status throughout the system lifecycle
• Involved in identifying critical defects, impact analysis, prioritizing the issues and leading the team to get the issue/bug resolved
• Assessed audit readiness of SLC package
• Created various reports and shared overall project health and status with the Leadership team
• Provided training and guidance on validation principles, regulatory requirements, and best practices
• Promoted compliance awareness and fostered a culture of quality and validation within the organization.

• Prepared comprehensive Validation Plan and Test Plan, outlining the validation approach and test strategy for the IQ system which does electronic submissions to FDA
• Authored and executed Operational Qualification (OQ) protocols, ensuring thorough testing and validation of system functionality
• Performed system testing, integration testing and end to end testing
• Identified requirement gaps and reported them to the Business Systems Analyst (BSA), contributing to the overall improvement of system requirements
• Reviewed test protocols, ensuring alignment with project objectives and adherence to validation standards
• Led a team of 5 testers, providing effective test management and coordination throughout the project lifecycle
• Conducted resource planning to allocate tasks and responsibilities efficiently among team members, optimizing productivity and meeting project deadlines.

• Evaluated Change Requests and performed impact assessments, ensuring effective management of project changes for various Quality-Critical web applications
• Conducted Requirement Analysis, aligning project requirements with validation objectives
• Authored and executed Test Plans, test cases, and validation test scripts, ensuring comprehensive testing and compliance
• Performed testing on web and mobile applications, ensuring compatibility and functionality across platforms
• Contributed to system certification by documenting test summary reports and supporting validation documentation filing and auditing
• Successfully managed multiple projects simultaneously, demonstrating efficient project handling and multitasking skills.

• Led as Test Manager, ensuring project success through effective oversight of testing activities
• Conducted requirement analysis sessions, providing accurate testing effort estimations and establishing a clear understanding of project objectives
• Developed and maintained the Test Plan throughout the project life cycle, optimizing team efficiency through resource planning and utilization management
• Performed Integration testing, UI testing, and End-to-End Testing, coordinating with interfacing application teams for system connectivity and issue resolution
• Held daily Test Defect review meetings, tracked defects, and published detailed status reports and Test Reports
• Conducted thorough review of testing deliverables before final sign-off.

• Supported testing for data migration project by writing and executing test cases to compare source and Target systems using SQL queries.

WellPointtional and Non-Functional requirements, flow charts, and use case diagrams

• Participated in System Test Plan Review, UAT, and provided support during production implementation
• Managed Change Control activities to ensure smooth project execution.

• Applied reverse engineering methodology to understand the existing PowerTrack system due to the absence of valid requirement specifications
• Analyzed proposed enhancements requirements to determine their impact on the system
• Conducted System Testing and Integration Testing to validate the system's functionality and ensure smooth integration with other components
• Created Test Plan, Test Scenarios, and prioritized tests to ensure comprehensive test coverage
• Configured Quality Center for efficient test management and tracking
• Took charge of preparing Test Reports and Test Execution Summary for management review.

• Served as Module Coordinator, responsible for daily status reporting and task assignment to meet client requirements
• Conducted various types of testing including GUI Tests, Regression Tests, Functionality Testing, Integration Testing, and Ad hoc Testing
• Performed ambiguity reviews of business requirements and functional specification documents to ensure clarity
• Configured test cycles in Test Director for effective test management and tracking
• Designed and developed test cases and conducted manual testing using Test Director
• Generated Daily Status Reports, Test Incident Reports, and Test Summary Reports to communicate testing progress and results.

• Acquired comprehensive knowledge of existing functionalities and complex business rules of the Financial Management System
• Developed and executed UAT test cases aligned with business requirements
• Collaborated closely with real end users to conduct post-production testing, accurately simulating real-time transactions in both the old and new environments for result comparison.