Graduate Degree in Life Sciences / Pharmacology /Public Health/ Nursing including the integrated PG degrees. Dept of Pediatrics, AIIMS Bhubaneswar. ESCHAR Trial
MS, M. Pharm, M.Tech, M.Sc. in Organic Chemistry, Pharmaceutical Chemistry, Process Chemistry, Medicinal Chemistry from a recognized University or equivalent
Post Graduate Degree including the integrated PG degrees in Science/ Biomedical Engineering/ Pharmacy / Bioinformatics / Life Sciences / Chemistry / Physics / Microbiology, with three years post qualification experience or PhD in Engineering or Technology
The candidate should have a masters degree (MS/M.Pharm/M.Tech/M.Sc.) in pharmaceutical chemistry/ Organic chemistry/ Process chemistry/Medicinal chemistry. NIPER, Hyderabad, against the ANRF funded project.
First Class Post Graduate Degree, including the integrated PG Degrees in Chemistry/Biotechnology/ Biological Sciences/ Pharmaceutical Sciences / Material Science/ Polymer/ Nanotechnology Degree, OR Nanotechnology. INST Mohali
Four year Bachelors Degree / BVSc / MSc degree, including the integrated PG degrees from a recognized University or equivalent degree in Life sciences and eight years' experience in R&D in industrial or academic/S&T institutions with scientific activities and services
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.
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.