Tushar Deore

 Handled ANDA & NDA projects. Logging, Evaluation and closure of Deviations, Incident. Handling, Logging and closure of Change control. Handling of market complaint. Actively participated in client as well as regulatory audits.  Preparation of Process Validation Protocol and Reports.  Participate in validation activities and planning for timely execution of validation as per approved protocol.  Review of Validation Reports against approved protocol.  Preparation and Review of validation summaries.  Maintenance documentation related to validation.  Preparation of Hold Time Study Protocol and Reports  Release of batches in SAP.  Review of Batch manufacturing Record and Batch Packing Record.  Inprocess control checks in manufacturing & packing operations & sampling.  Review of inprocess and finished data of Q.C.  Following Good Manufacturing Practices (GMP) in the plant.  Co-ordination with production, quality control and regulatory affairs Dept.  Improvement and continues review of existing SOP’s and system.