03 Aug
|
BAXTER
|
Ahmedabad
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Summary:
The person will be responsible for the execution, analysis and review of analytical work (method development, pre-validation, validation, technology transfer and analysis of stability sample) performed at Complex Product Development team, GPRD, following GxP practices.
The Person is also responsible to provide analytical support to Baxter Global, and Baxter’s Contract manufacturing sites as required.
Essential Duties and Responsibilities:
· To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides, iron formulations, etc. Assist in regulatory query responses for Complex Products.
· To perform testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis.
· To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence. Knowledge of published literature and databases is essential.
· To keep track of all activities related to product analysis, ensure completion in the
📌 Associate Scientist Ii, R&d, Complex Product Development Ahmedabad
🏢 BAXTER
📍 Ahmedabad