ASHRUTHA DEVARAKONDA

Email: admzg3@r.postjobfree.com

Phone: +1-475-***-****

Technical Skills

Validation: EDMS (Electronic Document Management System), AERS (Adverse Event Reporting System), Track Wise, Veeva vault, Salesforce, LCT (Label Change Tracker), 21 CFR Part 11 and Annex 11, GAMP 5.

Software skills: MS Office - Word, Excel, PowerPoint, Project, Outlook, Visio, SharePoint, Adobe, Minitab, ANSYS, CATIA, JIRA, HP ALM, Azure DevOps Education

Campbellsville University

Professional Master of Business Administration (PMBA) Aug,2020- Ongoing University of New Haven

Master of Science in Mechanical Engineering May 2017 Kakatiya University

Bachelor of Technology in Mechanical Engineering May 2015 Professional Experience

Client - Gilead Sciences, CA Oct 2018 – Present

Role - Validation Lead

Cognizant Technology Solutions, Test Analyst

Projects:

Information Request Management System (IRMS) – Gilead’s Adverse Event Reporting System hosted on Citrix. Sustainment releases on quarterly basis Medical Information Queue (Mi-Q) – Replacement project for IRMS, this system is hosted on Salesforce

Label Change Tracker (LCT) – System will be used by Gilead Regulatory Affairs to record changes in product labeling. Upgrade project from existing LCT system Submission Publishing System (SPS) – This system is Gilead’s information management system to compile, publish, manage, and review electronic submissions. Worked on sustainment releases on quarterly basis.

Responsibilities:

• Reviewed and approved user and functional requirements specification documents.

• Responsible for preparing validation plan and risk management strategy for user and functional requirements, in accordance with FDA regulations including 21 CFR Part 11.

• Analyzed user and functional requirements to develop test plan, test cases in HP ALM

(Application Lifecycle Management)

• Validated the requirements based on the Gilead’s risk-based approach

• Authored, reviewed, and approved IQ, OQ, PQ protocols

• Ensured validation engineers and other project teams are sufficiently trained on SOP’s to execute validation protocols.

• Trained project team members on HP ALM usage and provided them required access. Acted as project administrator in HP ALM for above-mentioned projects and coordinated validation execution.

• Managed testing and validation activities are going as per project schedule.

• Coordinated for IQ, OQ, PQ validation executions performed by development team, validation engineers and business users.

• Created defects for the issues found during validation execution in HP ALM.

• Worked with system manager, QA, development team, business team to resolve deviations.

• Ensured to re-test the test cases based on defects found, wherever applicable.

• Reviewed and approved executed IQ, OQ, PQ test cases in HP ALM .

• Reviewed and approved Requirements Traceability Matrix prepared by validation engineers, and ensured all the requirements are met.

• Reviewed and approved change controls for quarterly releases. Ensured all requirements are met for each change controls and performed relevant testing to ensure validation state of the system.

• Prepared, reviewed, approved Validation Summary Report (VSR).

• Archived all documents for paper-based executions to make sure they are following 21CFR Part11.

• Monitored UAT testing, reviewed reported bugs on Azure board. Ensured the testing for defects is covered during validation testing.

• Responsible for documenting meeting minutes and key outcomes, action items, logging risks and issues, weekly status reports, tracking work progress of validation activities on weekly basis in an excel or MS project plan.

• Collaborative work with validation engineers, developers, QA, Business subject matter experts

(SMEs), system managers and project managers.

Vastek Inc. 11/2017 – 10/2018

Client – Gilead Sciences, CA

Validation Engineer

Projects:

Regulatory Document Management System (RDMS) – Electronic Document Management system of Gilead regulatory documents, which was hosted on Documentum platform. Upgrade project from existing RDMS system

Eclipse Coding Tool – This tool will be used by Gilead’s PVE department to perform coding of medical terms and medications. It provides ability to import data for coding. Responsibilities:

• Developed test scripts for the user and functional requirements, based on risk-based approach.

• Worked on different methodologies like Waterfall, Agile projects

• Authored IQ, OQ, PQ protocols.

• Executed OQ, PQ protocol after each protocol is approved by all stakeholders in EDMS.

• Ensured that documentation comply with GDP (Good Documentation Practices).

• Validating in accordance with the 21 CFR Part 11 regulations.

• Identify any deviations and gaps in the testing procedure, documentation or configuration, and prepared recommendations for mitigation of the issues found.

• Documented deviations using approved templates, worked with development team and QA to resolve the deviations.

• Responsible for developing Data Migration Qualification (DMQ) protocol as per the defined data migration specifications.

• Executed Data migration qualification protocol with minimum number of protocol and tester errors.

• Performed root cause analysis, corrective action, review and reporting Reviewed documents.

• Prepared Requirements Traceability Matrix (RTM) for all streams.

• Authored validation summary report and archived all documents to make sure they are in compliance with 21 CFR Part 11.

Vastek Inc. 08/17-11/2017

Validation Engineer

Responsibilities:

• Create/update of master validation plan and other validation documents for existing products.

• Active participation in the gap analysis, checking for documents in the system and creating new documents for Test Method, Test Method protocols and Validation Reports.

• Performing and documenting qualification and validation testing to accommodate process changes for existing product lines.

• Facilitating/participating in FMEA’s for existing production processes.

• Author IQ, OQ, PQ protocols.

• Execute IQ, OQ, PQ protocols.

• Resolve any deviations occurred during executions.

• Re-executed test scripts to make sure the scripts are updated with current system specification and the system meets the functionalities specified in the URS and FRS.

• Write and review requirements traceability matrix to track user and functional requirements.

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