Kantha Rao Yachamaneni

Deputy General Manager @Harman Finochem Ltd

Aurangabad, IN

Responsible for handling of all aspects of Quality Assurance including in-process QA and Quality management system and ensuring Quality Compliance. Responsible for managing the Quality Management Systems ensuring market complaints, incidents, deviations. Out of Specification results (OOS) & Out of Trends (OOT) are investigated and corrective and preventive actions are implemented as per set timeline. Responsible for ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment. Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QA systems at the site. Execute Quality Assurance goals and strategy in line with Quality management objectives and regulatory requirements. Facilitate internal and regulatory agency audits, and ensuring compliance to the audit findings with implementation of appropriate corrective and preventive actions. Responsible for effective managing the change control and quality risk management process and providing approvals. Providing leadership and expertise to ensure achievement of all Quality Assurance goals, business and functional at site Streamlining of sampling plans with rationale to reduce the analytical workload on quality control lab.