Posted:6 days ago|
Platform:
On-site
Full Time
1. Perform analytical method validation for Assay, Dissolution, and Impurity methods.
2. Operate, maintain, and troubleshoot HPLC systems confidently.
3. Prepare and review validation protocols and reports.
4. Conduct forced degradation studies and interpret degradation patterns.
5. Handle comparative dissolution profiles (CDP) and evaluate F1/F2 similarity factors.
6. Work with S2 media and other required dissolution media.
7. Support impurity profiling and related analytical justification work.
8. Carry out risk assessment activities for method robustness and reliability.
9. Maintain accurate documentation and ensure data integrity.
10. Collaborate with QA/QC teams to address analytical challenges.
11. Troubleshoot chromatographic issues and instrument performance problems.
12. Support routine lab tasks including system suitability and calibration checks.
1. Strong hands-on experience with HPLC handling and troubleshooting.
2. Good understanding of validation for Assay, Dissolution, and Impurity methods.
3. Familiarity with CDP studies, F1/F2 calculations, and media requirements.
4. Experience with forced degradation studies.
5. Solid report-writing and documentation skills.
6. Ability to resolve analytical issues with a calm, methodical approach.
Anwita Drugs
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