Job Description

Job description To review and provide technical inputs on product development report (PDR), Master formula card (MFC) and Technology transfer (TT) documents, etc. To prepare product process-related risk assessment, protocols and reports for feasibility trials, scale-up batches. To execute trial and Scale-up batches, summary reports. To prepare and review Exhibit batches Batch manufacturing record (BMR) and Batch packaging record (BPR). To support regulatory filing by providing the intended commercial batch manufacturing record (BMR), Batch packaging record (BPR) and stability evaluation summary. To support regulatory in getting Test license, Import license, No objection certificate (NOC) and Manufacturing license by providing the necessary documents related to product and process. To review and provide Critical Process Parameters (CPPs) and Critical Quality Attributes (CQA) as part of the Annual Product Review. Initiation of New Product Introduction (NPI) procedure for new product manufacturing at the manufacturing site. Responsible for the implementation of Process Analytical Technology (PAT) in the manufacturing facility for process improvement. Having exposure and experience in working onto Injectable/parenteral, oncology projects.