vacancies

API batch manufacturing / synthesis / operations of various equipment such as reactors, centrifuge, distillation, filtration, etc. Shift handling

Hands-on experience in developing and scaling novel oral and parenteral drug delivery systems to improve solubility, bioavailability and/or overall product performance.

Support internal, customer and regulatory audits and ensure timely observation closure. Ensure GDP & Data Integrity compliance across production documentation. 

Prepare, compile and review regulatory submissions for ROW markets. Prepare CTD/ACTD dossiers for non-regulated markets.  Ensure timely dossier submissions and respond to regulatory queries. 

Good communication and analytical skills. Team player with the ability to complete tasks in a timely manner.

Troubleshoot instrument-related issues and malfunctions and coordinate for resolution wherever required. Prepare and review SOPs, protocols, worksheets and other applicable documentation in accordance with GLP and established SOP requirements.

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies.

To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.

Responsible for preparation and review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements.