Amneal Pharmaceuticals Ahmedabad Vacancy  DMF reviewer  – R&D Injectables

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