Job Description
- ,Perform routine and non-routine quality control analysis of raw materials, packaging materials, in-process samples, and finished pharmaceutical products in accordance with approved specifications and pharmacopeial methods.
- Conduct HPLC analysis for assay determination, related substances testing, and impurity profiling of APIs and finished dosage forms.
- Perform UV-Visible spectrophotometric, FTIR, and Karl Fischer, melting point analyses as required.
- Carry out dissolution, comparative dissolution, and disintegration testing to support product equivalence and process optimization.
- Ensure accurate analytical weighing and proper use of analytical balances.
- Execute analytical method validation and verification in compliance with ICH guidelines and GMP requirements (accuracy, precision, linearity, robustness, specificity).
- Support and manage stability studies including accelerated and long-term studies across relevant climatic zones.
- Monitor and trend stability data and ensure proper operation and monitoring of stability chambers.