Title: Executive - Analytical Development

Date: Oct 24, 2024

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

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