Summary
Overview
Work History
Education
Skills
Hobbies and Interests
Projects
Languages
Timeline
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VENKATA SUBRAHMANYAM KOLIPAKA

Boston,USA

Summary

I am a driven graduate student at Northeastern University with a background in pharmacy and practical experience gained through internships and professional roles. My primary focus is on ensuring GMP compliance and managing batch disposition in pharmaceutical manufacturing. I have a strong understanding of Quality Assurance processes, including reviewing batch records, managing the disposition of raw materials and finished products, and ensuring that products meet regulatory and quality standards. My dedication to lifelong learning and staying up to date with industry regulations enables me to contribute to batch disposition, quality assurance, and GMP compliance efforts, ensuring that high-quality medicine reaches the market efficiently.on of successful products.

Overview

3
3
years of professional experience

Work History

Pharmacist

Meri Medical Store
Eluru
11.2020 - 06.2022
  • Reviewed prescription to confirm appropriate selection of drug, and dose and check for interactions with other medications.
  • Interpreted prescription orders, dispensed medications, and counseled patients on drugs.
  • Educated patients about possible drug interactions and gave special administration instructions.

Formulation Intern

Yeluri Formulations Pvt. Ltd.
Hyderabad
04.2019 - 06.2019
  • Performed chemical studies on raw materials, in-process materials, and completed products to verify adherence to business standards and regulatory mandates, ensuring compliance with GMP requirements.
  • Reviewed batch records to confirm adherence to quality standards before product release.
  • Documented all laboratory tests and activities following GMP documentation guidelines.
  • Collaborated with colleagues from other departments to gather, arrange, and present data for Statistical Process Control studies, contributing to continuous improvement in quality systems.

Education

MS - Regulatory Sciences

Northeastern University
Boston, MA, USA
01.2024

Masters - Pharmaceutical Sciences,Pharmaceutical Technology

Andhra University
Visakhapatnam, AP, India
01.2020

Bachelor Of Pharmacy -

Andhra University
Visakhapatnam, AP, India
01.2018

Skills

  • Batch Disposition
  • GMP Compliance
  • Quality Systems Management
  • Regulatory Inspections
  • Non-conformance Review
  • Change Control Management
  • Six Sigma and Process Improvement
  • Safety and HSE Compliance

Hobbies and Interests

Environmental conservation, Theater, Cooking, Travel, Sports.

Projects

Northeastern University - Boston, MA, USA. Analysis of Sandoz's Omnitrope approval under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Omnitrope (Somatropin recombinant DNA origin) Injection, manufactured by Sandoz Inc., was given FDA approval on May 30, 2006. Preclinical safety data would have most likely been reported for biosimilars like Omnitrope are Pharmacodynamic Studies and Pharmacokinetic Studies.,

 Andhra University – Visakhapatnam, AP, INDIA. Comparative Studies of Mesalamine Products in The Indian Market, Comparing mesalamine medicinal goods, such as tablets, on the Indian market to research the rates of dissolution and prices of certain brands, as well as documenting the dissolution rate and the time taken for the drug to disintegrate into particles to create a project.

Languages

English
Professional

Timeline

Pharmacist

Meri Medical Store
11.2020 - 06.2022

Formulation Intern

Yeluri Formulations Pvt. Ltd.
04.2019 - 06.2019

MS - Regulatory Sciences

Northeastern University

Masters - Pharmaceutical Sciences,Pharmaceutical Technology

Andhra University

Bachelor Of Pharmacy -

Andhra University
VENKATA SUBRAHMANYAM KOLIPAKA