LEKHANA PALAKURTHI
Boston,MA
Summary
Aspiring intern with a passion for CMC, Quality Assurance, and Regulatory Affairs eager to leverage research and analytical expertise in a rigorous life sciences role. Driven to contribute to smooth product development through meticulous document management, data analysis, and regulatory agency interaction.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Control Associate Intern
Divi's Laboratories
Hyderabad, India
01.2020 - Current
- Developed and updated process documentation, assay protocols, and sampling strategies
- Acted as the Person-in-Plant (PIP) Support during production runs
- Analyzed and monitored quality control data, generating and distributing trend reports regularly
- Coordinated with cross-functional teams to ensure compliance with regulatory requirements and quality standards.
Education
BACHELOR OF PHARMACY -
Gitam (Deemed to Be University)
Visakhapatnam, India01.2023
MASTER OF SCIENCE IN REGULATORY AFFAIRS -
Northeastern University
Boston, MASkills
- Pharmaceutical Industry Expertise: FDA regulations, GMP, GLP
- Software Proficiency: MS Office Suite, Prism (Data Analysis)
- Communication & Organization: Strong skills, proactive, self-directed
- Multitasking: Effective in high-pressure environments
- Engineering Principles: Self-taught, current with industry advancements
- Health & Life Sciences: Project planning, adaptability
- Professional Traits: Energetic, flexible, adaptable to evolving requirements
Projects
Omeprazole Efficacy in GERD Treatment
- Conducted a research project evaluating Omeprazole's efficacy in treating Gastroesophageal Reflux Disease (GERD), highlighting significant symptom relief, improved esophageal healing, and a favorable safety profile. Demonstrated proficiency in analyzing patient outcomes and assessing drug efficacy and safety.
Pharmacokinetics and Efficacy of Extended-Release Ciprofloxacin
- Conducted a research project evaluating the pharmacokinetics and therapeutic efficacy of a new extended-release Ciprofloxacin formulation, demonstrating improved absorption rates, sustained drug levels, and enhanced antimicrobial activity compared to the standard version.
Certification
- Design and Interpretation of Clinical Trails - Coursera
- Intellectual Property in healthcare Industry - Coursera
- Pharma Drug Regulatory Affairs Course - Udemy
Timeline
Quality Control Associate Intern
Divi's Laboratories
01.2020 - Current
BACHELOR OF PHARMACY -
Gitam (Deemed to Be University)
MASTER OF SCIENCE IN REGULATORY AFFAIRS -
Northeastern University
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