Priyadarshani V.
Project Coordinator | Facility design | Estimating | CQV & Technical Documentation
- Role
- Analytical Chemist (Analytical R & d and Quality Control) at Aace Pharmaceuticals Inc
- Location
- Hoboken, NJ, US
- LinkedIn followers
- 500 followers
Experience
Analytical Chemist (Analytical R & d and Quality Control)
May 2024 — Present
Created and executed IQ/OQ/PQ protocols for newly acquired lab equipment, ensuring functionality, compliance with regulatory standards, and complete validation documentation- Oversaw equipment commissioning and decommissioning, coordinating activities to ensure smooth transitions, operational readiness, and adherence to quality and regulatory requirements- Developed and improved SOPs by identifying workflow inefficiencies, enhancing clarity, and implementing process changes that increased efficiency, reduced errors, and ensured regulatory compliance- Independently performed calibration and preventive maintenance of analytical instruments, ensuring data accuracy, consistent performance, and compliance with cGMP standards- Conducted analytical testing of raw materials, finished product, and controlled substances using HPLC, UV/Vis, FTIR, etc. to verify quality, purity, and potency- Prepared COAs for regulatory submissions and clients, ensuring accuracy, compliance, and audit readiness- Led QC lab change control activities, ensuring thorough documentation and compliance with GMP, FDA, and internal standards- Identified laboratory supply requirements for reordering to support smooth workflow and maintain inventory accuracy.
Education
Harvard Business School Online
Other; Certificate in Business Analytics
2021 — 2021
Stevens Institute of Technology
Master of Science, Pharmaceutical Manufacturing
2022 — 2023
London College of Fashion, University of the Arts London
Other; Certificate in Luxury Brand Management (Online Short Course)
2020 — 2020
Gujarat Technological University
Bachelor of Pharmacy , Pharmacy
2016 — 2020
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