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  • Method development & validation for Assay, RS & Dissolution, review & compilation of analytical data/ results/ documents for global market registration, preparation of analytical validation protocols, reports as per ICH guidelines, Installation

  • Review & Approve all QC raw data including analytical method validation report, protocols & raw data, implement Qlty Mgt. system & monitor activity, handling of Qlty system (OOS, root cause analysis, Deviations, Change Control, Effective CAPA Mgt ...

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