3 - 8 years
1 - 5 Lacs
Mumbai, Mumbai (All Areas)
Posted:1 month ago|
Platform:
Work from Office
Full Time
Role & responsibilities Timely completion of development and filing of products for Regulatory market (Oral solids, Tablet, Capsule, Pellets.) Work portfolio contains oral solid products in that IR and ER tablets and capsule, pellets systems. Product folio contains anti-inflammatory, antihypertensive, anti-depressant, anti- psychotic, duodenal ulcers liquid dosage forms, products etc. Timely completion of Documentation and other activity by coordinating with QA, RA, Analytical, IP and Purchase department like BMR, MFC, PDR, QbD documents etc. Contribution in the Documentation related activity (SOP review and preparations, QbD, Filing documents). Managing activities at External Interface with Vendors of Excipients and Vendors of API to ensure smooth and timely completion of activities. Responsible for carrying out preformulation studies, evaluation of physical and physicochemical properties of drugs to illustrate their influence on the stability of the intended formulation and release characteristics which includes decision of excipients and tests depending upon the product to be develop. Responsible for innovator product (RLD) characterization, design and perform formulation strategies & manufacturing process. Responsible for carrying out stability studies of APIs and drug product as per ICH guidelines, study of product behavior and dissolution profiles in different storage conditions. Responsible for carrying out formulation trials Responsible for carrying out Scale up and Exhibit Batches.
Navlakha Management Services
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