Review & extraction & segregation of updated documents from dossier. Review of product manufacturing Gap assessment, Raw material gap assessment & packing material gap assessment. Review of engineering batch/ scale up batch BMR & sampling plan.
Execution of Scale up batch, Exhibit batches at respective CMO’s. Review of batch reports, stability protocols & reports. Review of performing compatibility studies with respect to regulatory compliance.
Coordinating with cross function teams, collection and sharing technical documents with FR&D;, AR&D;, Production, Quality assurance, Quality control and Regulatory affair departments. Preparation and review of batch records like BMR, BPR, stability protocols, stability reports, IC BMR. Scale up batches execution & batch records review report.
Responsible for RM, PM, SFG and FG code creation for current products.
Analyze difference between equipment design and capacities and coordination with plant and other technical members in order smooth products transfer between R&D; to plant. Review and finalization of draft BOM, MFC, MPC packing stability protocols sampling protocols in coordination with R&D; production QA and documentation team.
Involve in trouble shooting during transfer monitor execution of transfer revision of documents and process validation in order to enable smooth products transfer between R&D; and plant. Support for manufacturing packing and engineering teams and trouble shooting for technical matters related to new projects new products introduction of smooth transfer of products from R&D; to plant. Responsible for all QMS activities related to technology transfer products.