Executive - RA (API)

Experience of compilation of drug master file (Restricted/Close and Applicants/Open

Parts), Tech Pack for all global regions.

• Should be able to review the technical documents received from R&D, Analytical and

Validation Team, QA, QC and Production departments at each and every stage of

manufacturing of API to minimize the errors during submission to regulatory agencies.

• Should have sound knowledge of ICH guidelines, Genotoxic Impurities and

Nitrosamine Impurities.

• Should be able to coordinate, review and check the studies like Risk assessment and

evaluation of Genotoxic and Nitrosamine impurities carried out at outside laboratory.

• Should have enough knowledge on evaluation of Key Starting Material in API

manufacturing from regulatory point of view. Should be aware of requirements for

KSM Specification.

• Should coordinate with formulation team for any of the API related work and review of

open part DMF received for formulations.

• Should be able to maintain the database for DMFs, regulatory documents, Customer /

MOH queries, updated documents received from internal departments for future

references.

• Good communication