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.
Refer code: 918438. Sun Pharma - The previous day - 2024-02-12 10:13
Address
