Sai Harshini Makkena is a Quality Specialist at BIOLYPH since March 2023, where responsibilities include conducting Batch Record Reviews and identifying Quality Systems errors in alignment with FDA standards. Additionally, Sai serves as a volunteer for ENCQR at St. Cloud State University, honing skills in Quality Management Systems and regulatory knowledge. Previous experience includes a Customer Service Representative role at Kohl's, a Scientific Data Analyst position at Excelra, and a PharmD Intern at NRI General Hospital in India. Educational qualifications consist of a Master's degree in Regulatory Affairs and Services from St. Cloud State University, expected in June 2024, and a Doctor of Pharmacy from Acharya Nagarjuna University, completed in June 2022.
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