·Successfully completed different regulatory audits and sponsor audits with zero or minor findings.
·Audit faced USFDA, WHO, ANVISA, DCGI and Turkey.
·Developed some challenging methods which require derivatisation, pre stabilization (unstable molecules) and high sensitivity.
·Reduced sample cost and sample processing error: Optimized selection of processing method, materials and documentation.
·Reduced Instrument down time: Training, preventative maintenance and seminar.
·Project Management -Reduced project time line: Optimized flow of documentation and review cycles.
·Explored and Implemented use of modern, robotics and most sensitive Instrument like UPLC-MS/MS, Liquid Handling system.
·Discovered, developed and retained top talent.
·Supervised 3 to 6 group of Scientists and other supporting staff.
·Supervised some cross functional areas like sample management group, vendor selection and purchase.