User: Drkrishnasarmapathy

To carry out  Quality assurance  and development activity in the field of Organic Chemistry, to make profit for the organization, motivate, guide & lead a team of scientists, Direct strategic planning and the development of goals allied with organization objectives for the Quality group. Ensure the development of talent for leadership roles and plan talent succession for Quality Specialty Operations. Key focuses on maintaining State Of Control, Quality, Compliance, robust and efficient service level and continues improvement.Recommend actions or policies that result in quality operational sites enhancements for compliance and inspection readiness, ensure that critical or strategic priorities at the regional sites are adhering to global quality policies and that sufficient quality oversight is demonstrated in all operational deliverables. Acting as Quality Program Lead for assigning projects to ensure appropriate quality of development and production within defined timelines. Representing Quality Operations in cross-functional project teams with responsibility for oversight of the overall quality of the project .Co-ordinate with inter department functions and manufacturing site functions for technical evaluations and review wherever required.
Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes Laboratory Process optimization, Operational Excellence, analytical excellence, compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum and other GMP system etc.). Up date knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial products.Hands-on expertise in highest quality standards, GMP compliance and build a quality orientated culture.and worked in regulated plants having approvals of US FDA, MHRA.etc.Hands-on experience in successfully handling and implementing cGMP (Current Good Manufacturing Practice) practices, quality management system, risk assessment, mitigation and Good Documentation Practices