Computer System Validation Lead
Xybion Pvt Ltd
12.2020 - 02.2023
- Organizing RIA (Risk Impact Assessment) meetings for a GxP assessment of the Application and 21 CFR Part 11 Assessment.
- Author, review & approval of all validation SDLC documentation (Validation Plan, Requirements documents, Test script, Traceability Matrix, Test Plan, Test Report Middleware RTM and Validation Report)
- Attend a Sprint Planning session to review user stories, estimate the story points for Validation services.
- Attend the Business Analyst team requirement understanding session to understand requirements and review URS and Perform the GxP assessment of JIRA tickets as per the URS classification and risk assessment once it ticket identified and moved sprint ready.
- Attend Daily standup, Sprint Demo, and Sprint Retrospective meetings with the project team.
- Reviewed the test results from Automation Testing (Jenkins & Katalon) as well as Manual Testing for System, Integration and Regression Testing during dry-run and formal testing.
- Create the Validation documents in Confluence (validation plan and Validation summary report) and review other SDLC deliverables in Confluence and share the feedback to the respective stakeholders.
- Route the documents to respective stakeholders for approval in Veeva Vault Electronic Signature tool as per roles and approvers from SOP.
- Working on a change management process by using ServiceNow. Approve the CCs for Test, UAT and Production environments. Closing the CCs with respective deployments evidence.
- Store the signed documents into the respective project folder in Veeva Vault Document Management System (Veeva Quality Docs) as per the system version and release number.
- Trained staff and users to work with computer systems and programs.
- Maintained quality-focused performance benchmarks and schedules when directing project teams