I am an industrious Quality Assurance Professional with experience of more than 30 years across performing for GMP standards as per regulatory norms in Pharma API units. I am spearheading efforts across implementing operational strategies for the quality functions by carrying out quality planning to confirm the organizational quality requirements. I have been instrumental in conceptualizing careful & sophisticated quality assurance measures in compliance to the specified standards while performing root-cause analysis to prevent any reoccurrences & defective issues. I have demonstrated functional excellence in enforcing observance of quality assurance / control systems to maintain parity with global quality assurance standards and promote quality-centric image of the company. I also have proven capabilities in review of data for new projects as per the cGMP requirements and handling OOS / OOT investigation, CAPA and quality related documentation. In the course of my association with various organizations, I have been shouldering the responsibility of designing and implementing systems and procedures to facilitate smooth functioning of overall quality operations and enhancing operational efficiency and have successfully facilitated ISO/GMP/USFDA/EU and customer audits. I have been consistently working toward the achievement of operational standards by providing significant inputs for the development of strategic plans and reviews . My basic objective is to go an extra mile for ensuring the development of the team and utilize my knowledge and experience for finding techniques and solutions for enhanced productivity. I always endeavour to strive for quality and apply process and discipline towards optimizing performance. My unique approach is to emphasize on restructuring core areas to enhance competency and thereby add value to the business. To know more, reach me at prashant12359@rediffmail.com