Job Summary:
Looking for motivated and skilled chemist with 1–4 years of experience in the Analytical R&D department. The candidate should have hands-on experience in HPLC method development and validation for Active Pharmaceutical Ingredients (API).
Key Responsibilities:
Perform method development for assay, related substances, and residual solvents using HPLC.
Execute method validation activities as per ICH guidelines.
Conduct routine analysis for method optimization and troubleshooting.
Prepare and review analytical method development reports (AMDR) and method validation protocols/reports (MVP/MVR).
Maintain proper documentation and follow GLP and GMP practices.
Support process development and stability studies by providing analytical data.
Ensure instruments (HPLC, GC, UV) are calibrated and maintained.
Handle raw data, results compilation, and analytical calculations.
Coordinate with cross-functional teams (QA, QA, Process R&D) for timely project completion.