Any M.Pharmacy / MSc with 6 to 10 Years or B.Pharmacy with 8 to 12 Years of relevant Experience in Manufacturing Downstream injectables with Strong people management experience in a regulated manufacturing operations environment.
Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval
Environment monitoring of aseptic area, Water sampling and testing, Sterility testing, Bioburden analysis and MLT analysis, Bacterial endotoxin test, Media preparation and handling.