Sr. QC Chemist
6 days ago
- 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
- 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, ₹950,000.00 per year
Benefits:
- Flexible schedule
- Health insurance
- Paid sick time
- Provident Fund
Work Location: In person
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