Ujwala Kondaveeti
Quality Assurance Analyst • Denton, TX • u*****************@gmail.com • 940****926 • drivetube.ai/•••••
Professional Summary
Quality Assurance Analyst with 3+ years of experience supporting GMP compliance, batch manufacturing and packaging record review, deviations, OOS investigations, CAPA and inspection readiness. MS in Health Informatics with strong data integrity and documentation skills, experienced in SOP and change-control maintenance and quality-system support.
Technical Skills
Databases: SQL
Testing: GMP Compliance,cGMP,Good Documentation Practices,Data Integrity,Batch Manufacturing Record Review,Batch Packaging Record Review,Deviation Management,OOS Investigations,CAPA Management,Change Control,SOP Development,Quality Management Systems,Document Control,Audit and Inspection Readiness,Regulatory Compliance
Data and Analytics: Microsoft Excel,Healthcare Data Analytics
Formulation & Laboratory Methods: Design of Experiments,Response Surface Methodology,Analytical Characterization
Documentation & Collaboration: Quality Documentation,Cross-functional Coordination,Investigation Reporting
Work Experience
Natco Pharmaceuticals
India
Quality Assurance Analyst
Jan 2023 – Jul 2024
Worked in pharmaceutical manufacturing supporting GMP production and quality release for generic drug products; provided documentation and investigation support for manufacturing and QC.
Tech Stack: Microsoft Excel, SQL, SOPs, CAPA records, BMR, BPR review, Document control
- Reviewed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) against approved master documents to ensure compliance and completeness, documenting discrepancies for corrective action and product-release files.
- Monitored on-floor manufacturing and packaging documentation for adherence to GMP, SOPs and approved procedures, advising production teams on corrective steps to prevent nonconformances.
- Supported deviation and Out-of-Specification (OOS) investigations by coordinating data collection, performing root cause analysis, documenting findings and drafting CAPA plans through closure.
- Authored and revised Standard Operating Procedures and change-control records to reflect process improvements and maintain traceable, inspection-ready documentation.
- Prepared and organized quality documentation for internal audits and regulatory inspections, responded to quality queries and supported corrective action implementation with Production and QC teams.
- Performed quality data checks and trend reviews using Microsoft Excel and SQL to validate release documentation and support data-integrity assessments.
University of North Texas
Denton, TX
Student Assistant
Jan 2025 – May 2026
Provided administrative and data support to a university department, maintaining confidential records, performing routine data checks and creating tracking tools to support faculty and staff operations.
Tech Stack: Microsoft Excel, Data validation, Record management
- Maintained confidential departmental records and performed routine data validation to ensure accuracy, privacy and reliable reporting for administrative processes.
- Designed and implemented Excel-based tracking tools for tasks, deadlines and project status to improve visibility and coordination across faculty and staff.
- Conducted routine data checks and reconciliations, identified discrepancies and coordinated corrections with stakeholders to maintain audit-ready records.
- Coordinated schedules, communications and event logistics for faculty and students, responding to inquiries and maintaining organized documentation.
- Assisted in preparation of departmental reports and documentation for reviews, ensuring records were complete and consistently formatted for auditing.
- Supported basic data extraction and query tasks to produce reporting tables and summaries used by staff for operational decisions.
Education
University of North Texas
Master of Science in Health Informatics • Denton, TX • May 2026
Chalapathi Institute of Pharmaceutical Sciences
Bachelor of Pharmacy • India • 2024
Certifications
Texas Registered Pharmacy Technician Trainee — Texas State Board of Pharmacy • Expires May 31, 2028
Registered Pharmacist — India
ICH-GCP Certification
Data Analytics Essentials
PTCB (in progress)
Achievements
- COI/IS Law Librarian and Legal Informatics Scholarship — Sarah K. Wiant: Awarded by University of North Texas for academic merit and scholarship in the legal informatics program.
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