Prashanth Kottari

ad4vw4@r.postjobfree.com

+1-201-***-****

EDUCATION:

Master’s in Medical Informatics March 2022 – JUNE2023 Sacred Heart University Fairfield CT

Bachelor’s in Pharmacy January 2016 – February 2020 CMR College of Pharmacy Hyderabad

PRACTICAL EXPERIENCE:

Quality Control Associate March 2020 – January 2022 Spectrum biocides Hyderabad, India

Successfully maintained compliance with regulatory standards and contributed to the improvement of product quality and consistency. Utilized LIMS systems, enhancing efficiency and accuracy in data management. Implemented corrective actions when necessary to address quality-related issues promptly. Assisted in the documentation and review of quality control procedures, maintaining accurate records of testing results and implementing corrective actions as needed. Engaged in cross-functional communication with production teams to address quality-related issues promptly, Contributed to the overall improvement of product quality and consistency through proactive teamwork and problem-solving. Conducted bioburden and membrane filtration testing, contributing to the overall quality assurance process. Contributed to the successful maintenance of GMP clinical supply API manufacture and supported regulatory inspections, ensuring conformance with applicable regulations and company procedures.Facilitated the manufacturing of high-quality API products for clinical supply, making independent batch release or reject decisions and supporting continuous quality improvement initiatives.. Improved visibility and accountability in training management, ensuring timely completion of training requirements and adherence to regulatory standards. Quality Control and Quality Assurance intern May 2019-February2020 Goldfish pharma Hyderabad, India

Assisted in preparing buffers, mobile phases for High-Performance Liquid Chromatography (HPLC), and calibrated laboratory equipment, maintaining meticulous records of activities and results. Contributed to analyzing stability samples, interpreting data, and conducting dissolution, assays, content uniformity tests, and blend uniformity assessments. Collaborated with QA department to revise SOPs and maintain logbooks. Ensured full compliance with GMP, GLP, and ICH/FDA guidelines in all analytical laboratory activities, resulting in successful regulatory inspections and audits. Assisted internal audits to assess compliance with quality systems and regulatory requirements.

SKILLS:

INSTRUMENTS HANDLED: HPLC, UV-Visible Spectroscopy, Dissolution Apparatus (USP I&II), Disintegration testing, pH Meter, (DSC, TGA) Karl fisher titrations, Fourier-transform infrared spectroscopy

(FTIR).

SOFT SKILLS: Problem-solving, Attention to Detail, Critical Thinking, Decision Making, Leadership, Teamwork, Organizing, Planning, Strong written and oral communication, Project Management, Root cause analysis, Understanding device specifications.

OTHER: MS office (Word, Excel, PowerPoint).

ACADEMIC PROJECTS:

ANALYTICAL DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD: Method Development & Validation on Omeprazole and Domperidone by Reverse Phase – HPLC method. To estimate Omeprazole & Domperidone simultaneously in capsule dosage form by RP-HPLC method. We utilized Degassed acetonitrile: Water in varying ratios and successfully achieved our desired outcome with a ratio of 40:60. Retention time for Omeprazole and Domperidone was determined to be 3.215 and 4.802 respectively using the HPLC – Agilent Model NO:1260/7 series.

Capstone Research Project- “Mobile Applications Improve Health Outcomes for Diabetic Patients.”