Job Description

Title: Executive - FRD Orals
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Date: Jul 31, 2024
Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd





• Literature search, product understanding, data interpretation for product to be undertaken for development.





• Initiation of documents required for product development/movement like T-License, Import License for drug substance as well as reference product and bioequivalence study request.





• Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader.





• Planning and execution of product development work to achieve desired product profile and data compilation.





• Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned.





• Packaging, labeling of batches and initiation of stability studies as per requirement of the product. Monitoring of stability study data of batches and updates on project movement.





• Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation.





• Laboratory notebook writing and assistance in documentation of controlled documents and compilation of the development data.





• Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations, in consultation with group leader.





• Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc.





• Ensuring the compliance of the various SOP/guideline/general procedures for better functioning of the department.