Shivaraj Gowda Email and Phone Number

Formulation Development and Technology Transfer of Product ( Product developed and Technology Transferred to GMP site)

R&D- Process Development and Technology Transfer of Oral solids ( Transfer of Developed product from R&D to scale up and scale up to Exhibit/ commercial)

Execution of Process feasibility batches / scale up batches at R & D and pilot plant /other units, supporting and addressing the scale up batch related issues.Selecting the suitable operation method, facility requirements, equipment’s for effective scale up and trouble shooting in process of scale up activities.Identify the bottlenecks in the entire process well in advance and facilitate solution for smooth and effective Technology Transfer.Monitoring of filing batches (Exhibit batches) and Evaluation of critical process parameters, process safety study of in-process checks, suggestion for changes for process feasibility and provide the necessary document support for process changes by initiation of the deviation/change controls & providing justification reports/investigation reports for the same.Co-ordination of cross functional teams and aligning as per the projects needs for delivery as per committed timelines.Preparation and review of documents like Feasibility report/scale up/Pre exhibit batch report and review and approval of documents like BMR, PVP, HTSP, BPR and PVR for exhibit batch required for regulatory submission.Facilitating the Product Technical Presentation to Commercial –TT, Production, QA and other cross functional team for better understanding of process and its critical parameters.Review of Technology transfer documents and Supporting for technology transfer of assigned projects from pilot scale/exhibit scale to commercial scale for achieving the process validation.Involved in trouble suiting of commercial products by continue monitoring of Process.Conducting Technical Training/Assigning GMP Training to Team by LMS (Learning management system).SAP related activities- Verification of RM and PM stock, PO Creation and Posting of Batch.

Evaluation of Product Tech pack (Received from Sponsor/customer) and understand product requirement, critical process parameters and any additional requirement for product Technology transfer.Preparation of gap analysis for manufacturing process and equipment by comparing the Tech pack received from Sponsor/customer.Risk assessment and risk mitigation plan for manufacturing process before execution based on the process criticalities and available equipment’s in site.Proposal of batch size for site transfer products based on product requirement, equipment suitability and annual requirement of finished product.Derive the QbD (Quality by Design) of the product with available Tech pack data or Development report before executing the batch (Scale up/ Process Optimization/Validation batch) to achieve QTPP’s (Quality Target product Profile Parameters).Requesting to create the raw material, semi-finished goods and finished goods code for new materials and new products.Preparation and review of MFR’s and MPR’s of new product.Documents reviewing (Protocol, BMR and Process Validation Report) of process optimization batch and Validation batch.Preparation of CAPA reports, Handling (evaluation and closure) of Change control, Incident (Unplanned), Deviation (Planned) and preparing the investigation reports for the same.Preparation & compilation of Trial, Scale up as well Process Optimization batch results and preparation of reports.Proposing recommendations for process (if any changes) and revision of process parameters (If required as per sponsor requirements) based on the scale up/ process optimization batches.Perform feasibility trial/ scale up trial/ in order to understand process and fix the critical parameter for smooth Tech transfer of product.Execution of Exhibit/validation batches successfully at GMP site to file different Regulatory markets approval.After Approval of Project Monitor the initial (3 batches) commercial batches for successful commercialization.

Technology Transfer-Oral solids, Oral liquids and Semisolids