Cephas Life Sciences Private Limited

Plan and perform extractable & leachable studies for container-closure systems, medical devices, and drug products. Operate and maintain analytical instruments ( GC-MS, LC-MS/MS, ICP-MS ) for impurity profiling. Develop/validate methods for trace-level detection of leachable (ppm/ppb). Conduct risk assessments and toxicological evaluations (per ISO 10993-17 ). Prepare technical reports and regulatory submissions (e.g., ANDA, NDA, CMC sections). Collaborate with toxicologists and regulatory teams to establish analytical evaluation thresholds (AETs) . Ensure compliance with GLP, GMP, and 21 CFR Part 11 standards. Job Types: Full-time, Permanent, Fresher Pay: ₹250,000.00 - ₹950,000.00 per year Benefits: Flexible schedule Health insurance Paid sick time Provident Fund Work Location: In person