Baroda, IN
6 days ago
Manager- FRD Non-Orals
M. Pharm with good exxperience in  Formulation Research and development Experience of Peptides Injectables dosage form with Experience in Drug Device Combination Products. Execution of Various Pre-Formulation, Compatibility, Hold Time & Stability Studies. Experience in technology transfer activities to plants Scale-up & Exhibit batches – Troubleshooting & Technology transfer Documentation i.e. Master Formula Record, Stability Protocol & Development Protocol & Reports. Preparation of Regulatory Filling Documents (Strategy document, Product Development Report, Nitrosamine, Elemental & Extractable Risk Assessment reports etc.) for advance regulated market of Peptides products Understanding about regulatory requirements of Peptides Injectables dosage form i.e FDA, EU, Canada, Brazil. Russia & Australia
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