Manager MSTG

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• Responsible for the MSTG-NOSD activity related Technology transfer of new products, site transfer products, commercial launches, LCM activities and CMO activities.
• Responsible for establishing new procedures, maintaining and updating existing procedures in the MSTG NOSD department.
• To co-ordinate with Cross Functional Team for execution of Trial, Scale-up, Exhibit, Process validation batches of new Products and commercial launch batches.
• Responsible for Support in regulatory Audit and Compliance & Query responses for Filed products.
• Handling & Support of Trouble shooting batches for data comparison and route cause Investigation for commercial products.
• Responsible for Review, comments and approval of MF, FMEA, RA, BMR & protocol (Sampling plan, Process validation protocol) and other technology transfer documents.
• Responsible for technical evaluation of new process technology in coordination with procurement team and finalization of User requirement specification.
• Technical support to plant operations team for upgradation to newer process technologies and better sterility assurance.
• Technical support for improvement in product robustness.
• Development of new vendors for process technologies.
• Responsible for overall development and training of the team members.
  

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