Senior Executive
SUN PHARMA
Date: 5 days ago
City: Vadodara, Gujarat
Contract type: Full time
- 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.
- Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation.
- 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.
- 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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