Deputy Manager Qa
CurrentReview and planing of analytical method validation, verification and method transfer. To evaluate the outside vendor DMF for the route of synthesis, impact of process related impurities and degradant impurities in drug product method validationsTo plan and monitor the FDA query related activities within the stipulated timelines.To plan and monitor the in-house methods/Pharmacopoeia methods evaluation and verification activities related to all analytical techniques for Drug products… Show more Review and planing of analytical method validation, verification and method transfer. To evaluate the outside vendor DMF for the route of synthesis, impact of process related impurities and degradant impurities in drug product method validationsTo plan and monitor the FDA query related activities within the stipulated timelines.To plan and monitor the in-house methods/Pharmacopoeia methods evaluation and verification activities related to all analytical techniques for Drug products and Drug substances.Review of the test method against pharmacopeia, DMF (Drug master file).Review of analytical method validation gap analysis.Review of forced degradation data. Review of impurities profile. Show less
