Executive Technology Transfer
1 month ago
Responsibilities
: 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. Responsible for transfer of technology in planned approach with proper documentation (in concordant with the quality system) which shall covers all aspects of product development, manufacturing and quality control. 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 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. Toensure that the appropriate process validations of a product and calibration/qualification of equipment are performed and recorded and the reports made available.
Required Skills :
Logical thinking. Organizing. Good in communication.Required Qualification: - B.Pharm/M.Pharm
Salary: - Upto 9.00 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
Key Skills :
R&d Bmr
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