Amneal Pharmaceuticals is Hiring a DMF reviewer for R&D Injectables at Amneal Pharmaceuticals Pvt. Ltd – Ahmedabad
– Position : 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 apeksha.langhanoja@amneal.com