Navneet Sharma Email and Phone Number

Manager Quality Services (2008-2009),responsible for batch review and release, review and approval of non-conformances, driving product quality improvements by coordinating investigations, carrying out root cause analysis, corrective and preventative actions. Provide appropriate assistance in floor issues, which may impact manufacturing, filling and packaging operations.Manager Microbiology (2007-2008), Responsible for all aspects of microbiological activities associated with aseptic filling operations, including testing, investigations, aseptic training and sterility assurance. Provided the necessary leadership for compliance with microbiology standards and regulations.Manager, QA pm shift (2006-2007), in addition to responsibilities indicated in Quality Services Manager, provided necessary leadership for compliance with quality standards and regulations and to facilitate the continuous improvement of process and product quality. Review and approval of documents e.g. change requests, validation, etc. Assistance in regulatory and vendor audits.Managerial duties including setting of objectives for all associates, performance management ensure that appropriate training is provided, succession planning, budget control, etc

Responsible for the management and organization of QC Dept, ensuring that various activities associated with protein fractionation are carried out efficiently and in compliance with appropriate company and regulatory procedures. This involved both Biochemical and Microbiological testing. Training and implementation of safe work practices.Other responsibilities include, release of raw materials, training, budget control, implementation of Quality systems and Lean manufacturing concept, provide the necessary production support and interact cross functionally, review and approval specifications, SOP’s, batch and validation documentation. Stability studies, CAPA, internal and supplier audits, continuous improvement.

Responsible for all aspects of microbiological activities associated with sterile and non-sterile manufacturing, fiscal management including budgeting, project management, provision of leadership to 16 employees, product development, stability, investigations, training, regulatory inspections including other internal and external audits and submission applications. cGMP, GLP and compliance issues. Managed media fills and filter validation studies. Maintained a close liaison with other departments and ensured that continuity of production was maintained and adherence to safe work practices

Managed Microbiological testing associated with both sterile and non-sterile products and support activities in accordance with company, regulatory and Pharmacopoeial requirements.

Carried out Microbiological and Biochemical analysis of antibiotics and analyzed Cytokines by using cell culture, ELISA and RIA techniques. Investigated into the mode of action of antibiotics. Monoclonal antibody production.