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Executive - Frd Orals

3 months ago

Tandalja Vadodara Gujarat, India Sun Pharmaceutical Industries Ltd Full time

**Title**:Executive - FRD Orals**:

- Date: Feb 5, 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.
- Planning and monitoring pre-formulation studies and compilation.
- Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned.
- Packaging, labelling 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.
- Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc.
- Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations, in consultation with group leader.
- Preparation of filing documents like Product development report, Nitrosamine impurity report and Element risk assessment report (ERAR).
- Ensuring the compliance of the various SOP/guideline/general procedures for better functioning of the department.