Raviteja Guddati
@ravitejaguddati
Senior Validation Lead and Test Engineering Manager in clinical trials.
IndiaWhat I'm looking for
I am a Senior Validation Lead and Software Test Engineering Manager with over 10 years of experience in the clinical trials domain, focused on ensuring regulatory compliance and data integrity under FDA 21 CFR Part 11 and GCP guidelines.
I have led validation projects for electronic data capture systems, authored and maintained validation documentation, conducted risk assessments, and managed change requests to ensure safe, compliant deployments. I also manage and mentor testing teams, streamline regression suites, introduce exploratory testing, and collaborate with product teams to refine acceptance criteria.
My hands-on skills include API testing, database testing, and mobile/device testing, and I have prepared teams and documentation for internal and external regulatory audits while securing formal approvals from QA and system/business owners.
Experience
Work history, roles, and key accomplishments
Software Test Engineering Manager
Advarra India Pvt Ltd
Nov 2021 - Present (4 years 1 month)
Led testing and validation for clinical data systems, ensuring FDA 21 CFR Part 11 and GCP compliance; streamlined regression suites, introduced exploratory testing, and mentored a team of 5 to improve release quality and reduce execution time.
QA Lead
Alpha Clinical Systems
Jun 2015 - Oct 2021 (6 years 4 months)
Owned QA activities for clinical trials software, developed and executed test cases (including mobile and database testing), managed defect lifecycle, and reported test summaries to management to ensure product quality.
Education
Degrees, certifications, and relevant coursework
Bhimavaram Institute of Engineering and Technology
Bachelor of Technology, Electrical & Electronics Engineering
Completed a Bachelor of Technology in Electrical & Electronics Engineering in 2011.
Availability
Location
IndiaAuthorized to work in
Salary expectations
Job categories
Skills
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