Afreen K Email & Phone Number

Vizag

Puducherry, India

- Involving in technology transfer activities for pharma products from R & D to site and site to site transfers. - Exposure in technology transfer of Injectable products (Ampoules, Vials and PFS). - Exposure with technology transfer of products from R &D /Site (US, EU, Canada & India). - Hands on training with R & D lab trials, Process optimization batches and Exhibit batches. - Experience on preparation of technology transfer documents such as new product introduction, PO Protocol & reports, MFR, Risk assessment. - Experience on application of licensing activities such as NOC, Test license, Import License & manufacturing license. - Handling of ERP software systems for initiation of Procurement and coordinating with vendors for sourcing the materials. - Co-ordinate with CFT s (Production, Quality, Regulatory, Warehouse and R &D) for smooth and successful transfer. - Exposure on guidelines and requirements for ICH, USP, Stability, Filter validation, E &L, Glass delamination.