Responsible for Scale up and Tech Transfer to internal and External manufacturing sites (CMOs)Lead and execute site transfer activity of project to external manufacturing location.Provides Process-engineering expertise to technology transfer of Projects to internal and external manufacturing units.Support Process Validation, alternate API source and commercialization activities for Process transfer to external suppliers.Review of technology transfer documents and GAP analysis.Design. Plan and Perform Project related scientific/technical activates under minimum supervision. CMO/CDMO support to site operation manufacturing for personnel for supported Process.Trouble shoot the issues during scale up batches, review the protocols and reports that parts of TT dossier.

formulation and Development

OSD technology transfer from small scale to large scale for US & Europe MarketProcess validation and process development.Qualification of different equipments. Material indent, stock in RM store etc.OPERATION & VALIDATION procedure for HSMG, FBD, FBP, Co mill, Multi type Blender, Roll compactor, Extrusion and Spheronisation, CADPRESS –IV, HRC- SEZONG, Hard & Soft Capsule machine, Inlay Tablet (Press cota), Sifter, Stirrer, PLM, Tablet printing, Laser drilling.Cost Improvement Projects handled and successfully completed by changing the API source, Exepeints source, Process time reduction, Equipment utilization etc.To evaluate Critical Quality Attribute (CQA) & Critical Process Parameter (CPP) of product during validation batch and Exhibit batch which will help to give adequate knowledge about product during technology transfer.To ensure the preparation of documents like, Master Formula Card(MFC), Optimization report , scale up batch Protocol and Report, LNB (Laboratory note book), PDR (Process development report),Validation Protocol, Validation summery reports, Process Evaluation reports, sampling protocol and Risk assessment form. Reviews of Pre exhibit batch, exhibit batch and validation summery reports, BMR, SOP’s and take change control, Deviation, OOS, from Q.A. for any changes in SOP’s or BMR.To decide the batch size with respect to the equipment availability, capacity and regulatory requirement. Qualification and Calibration of Different Equipments, Process Validation, Exhibit batch, Cleaning Validation and preparation of documents.Site Transfer Product From US to India

Tablet manufacuring like Granulation, compression, coating related activities.SAP related activities.like Batch record, MRN note, purchase order, Material availability, and other.Qualification of different Equipments.Validation of different batches.Technology receiving from FND to Commercial plant.Calibration of different Lab scale equipments like Hardness tester, friability tester, DT Machine, Halogen moisutre analyser, weighing balance etc.Documentation and preparation like BMR, SOP, Qualification protocol, validation protocol, deviation, change control, Investigation reports, Market complain handling etc.