Job Description

Job Description Ensure scientific assessmentinto the “Manufacturability” of the product for a robust process developmentduring new product introductions, product site transfers and processvalidation. Technical Support during process optimization activities related to ProductTransfer & ProcessValidations. Technical input andknowledge sharing with team and Cross functional team (CFT). Root Cause Analysis, Statistical evaluationsand Trouble Shooting of existing commercial as well as site transfer products. Improving process capabilities, yields androbustness. Prepare, Review and Approval of technical documents like MFR, PORM, BMR,BPR, Risk assessment , protocols and reports for Trial batch, Hold timestudy, Stability study, Process validation, Exhibit or submission batchdocumentation, alternate vendor development and side transfer project. Support documentation teamin order to deliver end to end documents from development batches (exhibit) tocommercial lifecycle management. Show more Show less