Executive- Formulation tech transfer/PDL/ MSAT

Job description

Role & responsibilities

• To receive and understand the technology from FnD dept.

• To design optimisation for process parameters & participate in the trials at R&D.

• To transfer the technology from R&D to receivers site for the respective product.

• To monitor the TT demo / exhibit/scale up and optimization batches.

• To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches.

• To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.

• To get involved and observe in the TT demo batch with F&D.

• To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc.

• To take the exhibit batches at the manufacturing locations and take care for its trouble shooting.

• To prepare the summary reports.

• To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency  query responses.