Amneal Pharmaceuticals Ahmedabad Vacancy DMF reviewer – R&D Injectables
is Hiring a DMF reviewer for R&D Injectables at Amneal Pharmaceuticals Pvt. Ltd – Ahmedabad
: Executive/AM. –
Job Description for DMF reviewer :
Review of Drug Master File. Good understanding of Impurity profiling.
– Review of Characterization data (should know about techniques such as NMR, XRD, Mass, IR, DSC, and TGA).
– Review of documents like but not limited to Specification, Analytical procedure, Validation reports, Equivalency reports, JOS, and Stability data. – Well-versed with current agency requirements.
– Well-versed with ICH and Genotoxic impurities guidelines. – Good knowledge of Pharmacopoeia. – Must be from a Chemistry background.
– Preparation of reports (like Equivalency, Specific study, Investigation study) as per requirements. – Good communication skills, for coordination with a Cross-functional team.
– Candidates may share updated profiles at email@example.com
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