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Manage end-to-end regulatory activities for new product applications, amendments, variations, renewals, and post-approval changes.

To procure raw materials, packaging materials and Reference product in consultation with packaging / purchase department.

To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach.

He must be aware of good documentation practices and aseptic behavior. Person should have hands on experience in microbiological activities such as Sterility, BET, Antibiotic assay, MLT and Culture Handling.

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.

Dossier Preparation in CTD/ACTD/eCTD/National format. Must have Parenteral and partially OSD dosage forms exposure.

Experience in IPQA,QMS, Qualification & validation. Must having experience of API Pharma Industries.

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.