Vamshi Krishna Vallabhaneni Email & Phone Number

Hyderabad, Telangana, India

As a Principal Delivery Manager with extensive experience in Computer System Validation (CSV), Software QA/QC, I lead the successful delivery of high-impact products across Perigord’s life science solutions, while also managing the Quality Assurance (QA) function. My role involves overseeing the execution of validation activities and ensuring compliance with regulatory requirements, including 21 CFR Part 11 and Annex 11. Additionally, I provide strategic leadership for validation projects… Show more As a Principal Delivery Manager with extensive experience in Computer System Validation (CSV), Software QA/QC, I lead the successful delivery of high-impact products across Perigord’s life science solutions, while also managing the Quality Assurance (QA) function. My role involves overseeing the execution of validation activities and ensuring compliance with regulatory requirements, including 21 CFR Part 11 and Annex 11. Additionally, I provide strategic leadership for validation projects, working closely with cross-functional teams to ensure high-quality project delivery. Manage the Quality Assurance aspect of all projects, ensuring that validation efforts align with overall QA policies and regulatory standards. Lead and support internal audits and compliance initiatives to improve the quality of validated systems. Oversee the deviation management process and ensure the effective resolution of quality issues. Show less

Hyderabad, Telangana, India

Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 / Annex 11 requirements are met.Coach the implementation teams in the proper execution of validation documents.Evaluate proposed changes to validated computer systems and recommend level of validation activities required.Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses.Identify and… Show more Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 / Annex 11 requirements are met.Coach the implementation teams in the proper execution of validation documents.Evaluate proposed changes to validated computer systems and recommend level of validation activities required.Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses.Identify and qualify all computer systems which impact cGMP operations using a risk based methodology.Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan.Act as a CSV Lead for all validation projects (Product Validation, Implementation and R & D Projects).Execute or oversee the execution of validation plans and validation documents.Perform project management activities for CSV process within the scope of an overall system project.Work with overall project manager to include validation activities in implementation timelinesManage internal CSV resources to facilitate completion of qualification activities.Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.Work closely with QA Compliance to ensure appropriate validation of cGMP computer systemsConduct or facilitate validation and 21 CFR Part 11 / Annex 11 training. Show less

Hyderabad Area, India

Hyderabad Area, India

Hyderabad Area, India

Manage assigned projects for testing. Estimate time, resources and budget required. Define Strategy, Build test team of professionals with appropriate skills, attitudes and motivation. Identify Training requirements. Develop test plan for tasks, dependencies and participants required to mitigate risks to system quality and obtain stakeholder support for this plan. Test Environment Setup, Task Assignments and Occupancy coverage. Ensure content, structure of Testing documents are documented and… Show more Manage assigned projects for testing. Estimate time, resources and budget required. Define Strategy, Build test team of professionals with appropriate skills, attitudes and motivation. Identify Training requirements. Develop test plan for tasks, dependencies and participants required to mitigate risks to system quality and obtain stakeholder support for this plan. Test Environment Setup, Task Assignments and Occupancy coverage. Ensure content, structure of Testing documents are documented and maintained. Document, implement, monitor and enforce all processes for testing as per standards defined by the organization. Check / Review the Test Functions/Scenarios/Cases documents. Keep track of the new requirements / change in requirements of the Project. Organize the status meetings and send the Status Report to the Client. Act as the single point of contact between various groups. Track and prepare the reports of testing results, test case coverage, required resources, defects discovered and their statuses, performance baselines etc. Ensure the timely delivery of testing milestones. Prepare/update the metrics dashboard at the end of a phase or at the completion of project. Show less

Hyderabad Area, India

Managing, Directing Testing Team, Designing Test, Test Delivery, Coordinating implementation. Allocating work, Time to resources and adhering to QA Processes. Providing test status and progress reports as appropriate to top management.

Hyderabad Area, India

Handling task scheduling, task allocation and providing support to the team/divisions in the development and quality control & assurance. Participated and Coordinated Development activities and checking readiness of builds. Tracking status, reporting and communicating with offshore team/client.

ERP Representative Management System which handles Work Related Tasks, Expense Reports, Hardware requisition forms, Software Updatations etc. This modules ("Representative”) of ERP supports Merck client with their application testing on upgrade or new requests.

Hyderabad Area, India

ERP Ticket management system which handles implementation support and testing. This ERP system supports Earthlink ISP.

Hyderabad Area, India

Supported GE Employees of Aeronautical Engineering & Rail Depts. (Transportation Dept.) worldwide with application support and testing on their Business applications, VPN (Virtual Private Network), Email Problems etc.

Master Of Business Administration (M.B.A.), Information Technology

Post Graduate Diploma In Project Management, Project Management

B.Sc., Micro Biology, Chemistry And Computer Applications

Master'S In Data Science, Business Analytics