To have a growth oriented and challenging career, where I can contribute my knowledge and skills to the organization and enhance my experience through continuous learning and teamwork.
Overview
1
1
Certification
Work History
Laboratory Technician
Chalapathi Drug Testing Laboratory
09.2021 - 12.2021
Experienced in laboratory protocols, including handling and calibrating UV spectrometers, HPLC systems, and pH meters, while strictly adhering to SOPs for quality and safety assurance
Assisted in the testing and analysis of pharmaceutical formulations using dissolution apparatus, disintegration testers, and hydraulic pellet press, following SOPs to ensure data accuracy and reproducibility
Education
Master of Science - Drug Regulatory Affairs
Long Island University
Brooklyn, NY
05.2024
Bachelor of Science -
Chalapathi Institute of Pharmaceutical Sciences
India
08.2021
Skills
Completed a project on regulatory pathways in the US healthcare system, focusing on the roles of ANDA, NDA, and IND submissions in drug approval and clinical trial initiation
Gained foundational knowledge in GLP and GMP regulations through coursework in regulatory affairs, focusing on quality control and compliance standards in the pharmaceutical industry
Developed a foundational understanding of medical device regulatory submissions, including510(k) and PMA processes, through coursework in regulatory affairs and FDA compliance
Conducted dissolution and disintegration tests on pharmaceutical samples as part of my internship, applying industry-standard techniques to assess drug quality and performance
Conducted quantitative analysis using HPLC and UV spectroscopy in a controlled lab environment, learning to interpret data and troubleshoot common equipment issues
Studied quality control techniques and quality assurance processes focusing on the importance of accuracy, documentation, and regulatory compliance in manufacturing
Certification
HACCP
SIX SIGMA
ACADEMIC ACTIVITIES
Attended International Symposium on the living Heart and Virtual Human twin which involves Regulatory innovations and Clinical care.
Presented a template example of Investigational New Drug Application in regards of regulatory submission to FDA.
Evaluated the Anti-microbial and Anti-bacterial properties of Oxadiazoles and characterized with IR Spectroscopy.
SOFT SKILLS
Skilled in clearly conveying complex information to team members and presenting findings in written and verbal formats
Exhibited strong interpersonal skills through active listening and constructive feedback during group discussions
Exhibited adaptability and a growth mindset by embracing constructive criticism and applying new approaches to improve my performance.
Timeline
Laboratory Technician
Chalapathi Drug Testing Laboratory
09.2021 - 12.2021
HACCP
SIX SIGMA
Master of Science - Drug Regulatory Affairs
Long Island University
Bachelor of Science -
Chalapathi Institute of Pharmaceutical Sciences
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