LAVANYA KAMBHAMPATI
New Jersey,United States
Summary
Detail-oriented and motivated Master’s student in Drug Regulatory Affairs with strong academic and practical foundations in pharmaceutical quality control and analytical chemistry. Hands-on with key instruments such as HPLC, UV-Vis, FT-IR and dissolution apparatus. Demonstrates keen interest in regulatory compliance and analytical R&D with working knowledge of FDA guidelines, ICH standards, and SOP documentation. Eager to contribute to your company mission by applying technical, analytical and regulatory knowledge in a fast-paced laboratory setting.
Overview
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1
Certification
Work History
Junior Pharma Intern
Assurgen Pharma Private Limited
06.2024 - 07.2024
- I engaged extensively with Quality control, Quality assurance and Production departments gaining a holistic view of pharmaceutical manufacturing and compliance.
- My work involved ensuring adherence to regulatory standards, preparing for audits, and supporting the preparation of regulatory submissions.
- I deepened my understanding of regulatory requirements and quality management systems essential for drug development and approval.
- Assisted in wet chemistry techniques including titrations, loss on drying, and residue on ignition.
Summer Intern
Chandra labs
05.2024 - 06.2024
- Trained in operating HPLC, GC, FTIR, UV-Visible spectrophotometer, dissolution and disintegration apparatus, punching machine and coating pan.
- Gained hands on experience in the Analytical R&D department, undergone various analytical tests.
- Acquired skills in Microbiological testing and analysis, ensuring adherence to laboratory standards and procedures.
- Assisted in quality control processes, ensuring the accuracy and reliability of test results and maintaining compliance with regulatory standards.
- Conducted data analysis and interpretation, preparing detailed reports on experimental findings and contributing to research projects.
Education
Master of Science - Regulatory Affairs
Long Island University
Brooklyn, NY05.2026
Bachelor of Pharmacy - Pharmaceutical Sciences
Shri Vishnu College of Pharmacy
Bhimavaram05.2024
Skills
- Regulatory: IND, NDA, ANDA, Drug Master File, Common Technical Documents (CTD, eCTD), Knowledge of Regulatory Regulation (EMA, USFDA, TGA, Health Canada, PMDA and CDSCO)
- Clinical: Clinical Trail Protocol, Investigator, Brochure, Informed Consent Form, Clinical Documentation, Patient assessment, drug administration, patient counseling
- Technical Skills: Microsoft Word, Excel, Powerpoint
- Analytical Skills: HPLC, GC, FT-IR, Dissolution and Disintegration apparatus, Punching Machine
- Expert Abilities: Strong oral and written communication skills, problem solving, team work and Collaboration
Certification
- Certified Registered Pharmacist of Andhra Pradesh Pharmacy Council (APPC) INDIA, ensuring pharmaceutical expertise and regulatory compliance.
- Certified Six Sigma White Belt Training
Timeline
Junior Pharma Intern
Assurgen Pharma Private Limited
06.2024 - 07.2024
Summer Intern
Chandra labs
05.2024 - 06.2024
Master of Science - Regulatory Affairs
Long Island University
Bachelor of Pharmacy - Pharmaceutical Sciences
Shri Vishnu College of Pharmacy