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I have extensive expertise in implementing and maintain ISO/IEC 17025 quality management system, routine and advanced drug testing with various analytical techniques, including UV-visible spectrophotometry, Atomic Absorption ,HPLC, TOC, FTIR, and LPC, ensuring precise quality control and regulatory compliance. My method validation and troubleshooting skills allow for accurate and reliable results, while stability and comparability studies contribute to effective product lifecycle management. My role involves leading detailed validation processes and efficiently resolving analytical issues to support consistent quality standards.With strong experience in regulatory affairs, I compile and prepare CTD, eCTD dossiers, ensuring quality alignment with ICH, WHO, FDA, and BP, JP, USP standards for national and international compliance. My proficiency in these standards enables seamless regulatory submissions and ongoing compliance in global markets. My approach emphasizes precision, adherence to guidelines, and collaboration across departments to uphold product quality and market readiness.

As a QC Manager in Amson Pharma, I’ve built a strong foundation in ensuring our team meets and exceeds regulatory standards, from cGMP to FDA requirements. I work hands-on with my team, managing all aspects of lab operations—from raw materials to in-process and final product testing—while balancing quality with efficiency to keep everything running smoothly. With a focus on making processes better and faster, I’ve successfully implemented streamlined testing protocols, reducing turnaround times and improving result accuracy. I also lead internal and external audits, proactively address quality concerns, and collaborate closely with production and QA teams to ensure products are released on schedule. Creating an environment where continuous improvement is part of our daily routine is key to my approach, keeping our team engaged and committed to high standards every step of the way