Title: Executive - FRD Orals
Date:
Oct 26, 2024
Location:
Tandalja - R&D
Company:
Sun Pharmaceutical Industries Ltd
Job Description
- 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.