0 years

2 - 9 Lacs

Posted:1 month ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • 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

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