LAVANYA KAMBHAMPATI
JERSEYCITY,NJ
Summary
Quality Assurance & Regulatory Affairs professional with expertise in GMP documentation, QA compliance, and regulatory submissions (IND, NDA, ANDA, CTD/eCTD). Experienced in maintaining ALCOA+ data integrity and supporting QA audits. Proficient in analytical testing methods including HPLC, GC, FT-IR, and UV-Vis. Holds a Master of Science in Regulatory Affairs, reinforcing knowledge in quality systems and inspection readiness.
Overview
1
1
year of professional experience
Work History
Quality Assurance Intern
Assurgen Pharma Pvt. Ltd.
Visakhapatnam, India
05.2024 - 08.2024
- Supported QA documentation activities, including reviewing batch records, logbooks, and controlled documents.
- Assisted in change control documentation by updating records and tracking document revisions.
- Assisted in deviation documentation, collecting data and ensuring compliance with GMP and SOPs.
- Supported root cause analysis for minor deviations using basic QA investigation tools
- Collaborated with QA and QC teams to maintain audit-ready documentation.
- Performed QC tests (LOD, ROI, titrations) and documented results following ALCOA+ principles.
- Contributed to preparation of regulatory and QA reports for internal audits.
Undergraduate Lab Assistant
Shri Vishnu College Of Pharmacy
Bhimavaram,India
11.2023 - 04.2024
- Supported Analytical R&D and QA by performing instrument operation (HPLC, GC, FT-IR, UV-Vis).
- Assisted in QA review of analytical data, ensuring GLP compliance and proper documentation.
- Reviewed analytical data for completeness and accuracy, ensuring compliance with GDP standards.
- Prepared technical reports and test summaries for regulatory submissions, supporting QA audits.
- Ensured data integrity by maintaining accurate, traceable lab records.
- Ensured documentation compliance with ALCOA+ and GDP standards, facilitating audit readiness.
- Supported SOP compliance, document control, and audit preparation activities.
Education
Master of Science - Regulatory Affairs
Long Island University
Brooklyn, NY05-2026
Bachelor of Science - Pharmacy
Shri Vishnu College Of Pharmacy
India05-2024
Skills
- Quality Assurance : GMP, GLP, GDP, QA Documentation, Batch Record Review, Deviation Support, CAPA Support, RCA, Data Integrity (ALCOA)
- Regulatory Affairs : IND, NDA, ANDA, CTD/eCTD basics, FDA/EMA/CDSCO Guidelines, Regulatory Documentation, Audit Support
- Analytical & QC : HPLC (basic), GC (basic), FT-IR, UV-Vis, Dissolution Testing, Wet Chemistry (LOD, ROI, titrations)
- Tools & Software : Microsoft Word, Excel, PowerPoint, Google Workspace, LIMS (basic exposure)
- Professional Strengths : Attention to Detail, Communication, Teamwork, Time Management, Problem Solving, Adaptability
Timeline
Quality Assurance Intern
Assurgen Pharma Pvt. Ltd.
05.2024 - 08.2024
Undergraduate Lab Assistant
Shri Vishnu College Of Pharmacy
11.2023 - 04.2024
Master of Science - Regulatory Affairs
Long Island University
Bachelor of Science - Pharmacy
Shri Vishnu College Of Pharmacy