Malapati Gopikrishna

Project: WebMD-Medscape

• Responsible for managing the projects from requirements gathering to release of the project.
• Conducting Testing & validation activities to meet regulatory requirements and industry standards, ensuring compliance and customer satisfaction.
• Leading and managing a team, including task assignment, performance evaluation, and mentoring.
• Participated in Product Backlog, Sprint Meetings and all other Scrum meetings.
• Analyzed client requirements, created Project timelines and effort estimations.
• Created projects in Adobe Workfront based on the client requirements.
• Monitored the project progress and collaborated with various teams to deliver the projects in time.
• Prepared daily/weekly test status and deviation log reports.
• Prepared Client Deliverable Documents including Pharma 101 documents, Launch notices, SOP's etc.
• Monitored project execution and maintained timelines till the completion and conducted End-to-End testing.
• KT/Trainings provided to all the new joiners in the team.

Project: Caliber NSCMS, DMS

• Responsible for Testing & Validation Management to provide quality delivery to clients across multiple Products (Document Management System, NSCMS- Training Management System).
• Establishing and enforcing standard test processes and deliverables (including defect management and quality metric reporting) within the gated process to streamline testing and support automation and manual testing efforts.
• Supervising team members for ensuring timely project completion; developing quality standards through participating in the initial software development stages; validating and enhancing the existing plan and strategy.
• Preparing, designing, and leading the test strategy and test plan for all products/projects; reviewing activities such as requirements review, design review, and test case review.
• Executing the product / project using Agile methodology by following Scrum, Sprint planning & Backlog management.
• Coordinate and oversee the execution of test cases, including manual and automated testing, ensuring comprehensive coverage.
• Implement a robust defect tracking and management process, prioritizing issues and ensuring timely resolution.
• Ensure that the software meets quality standards and complies with project specifications and industry best practices.
• Set up and maintain test environments that mimic production conditions to facilitate accurate testing.
• Prepare or Review SDLC & validation documents like Test Plan, Validation Plan (VP), Functional Risk Assessment (FRA), Requirements Traceability Matrix (RTM), Test scripts & OQ Script, Test & Validation Summary report & Release Note documents.
• Ensure IQ, OQ, UAT, PQ cases are prepared and perform system validation/qualification before releasing the product.
• Ensuring that product meets 21 CFR Part 11 regulatory requirements.
• Oversee the creation and maintenance of automated test scripts, optimizing test coverage and efficiency.
• Preparation of the Deviation log report & Summary report.
• Identify and assess project risks related to testing and implement mitigation strategies.
• Act as a bridge between the testing team and project stakeholders, providing regular updates on testing progress and issues.
• Continuously evaluate and improve testing processes, tools, and methodologies to enhance efficiency and effectiveness.
• Allocate resources efficiently, ensuring that the team has the necessary skills and tools to perform their tasks effectively.
• Expertise In testing & validating the DMS and NSCMS with instrument Connectivity.