Job Description: * 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.
