Title: Executive - Formulation
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Date: Nov 21, 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.
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• 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.
• Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation.
• 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.
• 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, MF etc.
• Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations.
• Preparation of document for filling of product like product development report and query response documents.
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