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.
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.
Ensure assigned products remain in a validated and compliant state as per MS&T and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale up proposals.
Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff.
Degree / Diploma in Pharmacy from a recognized university. One year of experience in a medicine/drug store in a reputed hospital or a Government-recognized health centre.
IISc invites applications from motivated individuals with an established record of high-quality research for the newly created IISc Post-Doctoral Fellowships, PDF. Overseas Citizens of India and foreign nationals are also eligible to apply