Group Leader - ADL
Zydus Group
- R&d - Ptc Ahmedabad|ptc - Ahmedabad, Ahmedabad, Gujarat, India
- Posted
This job is closed: the employer no longer lists it.
Skills
Required
- DPC
- IVBE
- Spray Pattern
- Plume Geometry
- Delivered Dose uniformity
- APSD
- ACI
- NGI ⮚
- Nitrosamines
- ICH Guidelines
Preferred
- validation
- pMDIs
- DPIs
- SMIs
- Nebulizers
Responsibilities
- Method development, validation and method equivalency of Inhalation Products for inhalation tests, related substances and assay. (pMDIs, DPIs, SMIs and Nebulizers) ⮚ Performed Drug product
Requirements
- Characterization study (DPC) and IVBE study for US, Europe, and Canada market for Inhalation products. ⮚ Method development, validation of Spray Pattern, Plume Geometry by Spray View. ⮚ Method development and validation of Delivered Dose uniformity.
- Aerodynamic Particle Size Distribution (APSD) By ACI and NGI ⮚ Familiar with Nitrosamines Impurities, Extractable & leachable, ICH Guidelines and Regulatory Submissions.