Officer to Executive-Technology Transfer

• To co-ordinate between R & D / client (product transferring unit) and all applicable stake holder departments in the plant (receiving unit) so as to ensure the smooth and effective transfer of product.
• To evaluate / review the necessary documentation provided from transferring party (from R & D, Client etc.) with respect to product and process criteria in terms of facility, available equipment’s etc.
• To review of product development summary report from transferring site in order to gain / understand the product as well as process knowledge and to ensure the smooth transfer of any new product to receiving site by organizing a proper and systematic meeting / discussion with involvement of all relevant stake holders from both transferring and receiving site.
• Responsible to ensure the clarity, accurate information, adequate communication / feedback in order to improve the understanding and to maintain the transparency of new product which is to be transferred.
• Responsible to prepare of batch documents like MFC, MPR, BMR, BPR, protocol, report and other technical documents (if any) with respect to R & D scale / pilot batch(s), scale-up batch(s), pre-exhibit / confirmatory batch(s), exhibit / submission batches.
• To monitor and provide assistance during execution of submission / exhibit batch(s) and initial commercial validation batch(s) of any new product as R & D representative based on the minimum criticality / lower risk criteria towards the process / product.
• To provide necessary assistance regarding challenges faced during execution scale-up, pre-exhibit / confirmatory, submission / exhibit batch(s) and also initial commercial validation batch(s) i.e., PPQ batch(s) in terms of deviation / incident investigations and to frame necessary Corrective Action and Preventive Action (CAPA) towards way forward activities.
• To participate in meetings, telecom etc. between inter/intra-departments and also with clients (if applicable) related to new product transfer, status update and filing / submission aspects.
• Responsible to take care Sample registration work for different Regulatory/Non-Regulatory market.

To ensure that the appropriate process validations of a product and calibration/qualification of equipment are performed and recorded and the reports made available.