Executive - FRD Orals

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.