Title:  Executive - Analytical Development

•             Specification & ATP preparation, review and approval for drug substance, drug product, excipient & packaging material for new product for all markets.

•             Analytical activities related to  Extractable & leachable method development & stability analysis of drug product on LC-MSMS, GC-MSMS, ICP-MS, ICP-OES etc..

•             Drug substance & drug product support for Life cycle management related to documentation for all markets.

•             Provide support to respond the regulatory query.

•             Support to plant location for documentation related work.

•             Specification finalization meeting for drug substance and drug product.

•             Co-ordination with development team, non-oral group leads and PMO’s for

documentation related activities on requirement basis.

•             Responsible for review of analytical documents in terms of Technical reports and Justification reports, which are submitted to various agencies.

•             Review of out source drug master file related documents.

•             Responsible for smooth functioning and co-ordination across various sites for harmonization and simplification.

•             Support for the filling related activities on requirement basis.

•             SOP review on requirement basis. (LIMS, LMS training)

•             Technical report/MFF/Monograph/gape/Harmonization code related activities.

•             Support for the Pharmacopoeial Compliance related activities on requirement basis.