Aishwarya Naik

Experienced Quality Control and Regulatory Affairs Specialist with a solid background in the pharmaceutical and biopharma sectors. Skilled at cGMP manufacturing, analytical chemistry, and cross-functional collaboration for regulatory compliance. Proven success in audit readiness, process improvement, and documentation, ensuring adherence to EU and US FDA standards.

cGMP Manufacturing & Compliance, Documentation, Root cause Analysis & CAPA, MES & SAP system, Batch record review, Regulatory eCTD submission, Process improvement, Pharmacovigilance, Analytical-testing.

Available on request

• Dietary Counselling and Nutritional Outcomes in Tuberculosis: A Randomized Controlled Trial.
• CMC Dossier Preparation - salmeterol and fluticasone propionate inhaler.
• Performed quantitative and qualitative analyses on pharmaceutical compounds using titrimetric, spectrophotometric (UV-Vis, IR), and chromatographic (TLC, HPLC, paper chromatography) techniques, achieving high data accuracy, molecular weight calculation, chemical kinetics, and organic mixture separation.
• Operated, calibrated, and validated advanced laboratory instruments including pH meters, flame photometers, potentiometers, conductometers, spectrophotometers, and colorimeters for dosage formulation, trace element analysis, purity testing, and pharmaceutical quality control.
• Executed a capstone research project demonstrating proficiency in Good Laboratory Practice (GLP) through the preparation and analysis of aspirin, ibuprofen, and vitamin C formulations. Carried out dissolution profile studies and method validation protocols to verify analytical reliability and adherence to safety and regulatory guidelines.
• Thesis on 'Impact of Pricing Strategies on Pharmaceutical Sales in India'

International Art of Living volunteer with over 4 years of experience organizing global events, conducting yoga and meditation sessions both online and offline across Ireland, skilled in classical dance, and multilingual communication