- Responsible for execution of Analytical Method Transfer / Analytical Method Validation / Analytical Method verification / Analytical method feasibility activities / other activities for drug substance / drug product / excipients.
- Responsible for qualification/ maintenance/ handling of working standards/ reference standards and impurities.
- Responsible for performing RLD analysis and COA generation.
- Responsible for preparation of risk assessment report of Nitrosamine / Elemental impurities / Residual Solvents.
- Responsible for performing the qualification and calibration of analytical instruments like HPLC, UV-Vis spectrophotometer, IR and other standalone instruments (like water content, pH meter, Balances etc.,).
- Responsible for preparation/ review / approval of protocols / reports / standard operating procedures.
- Responsible for performing investigation / reporting of the raised notification during AMV activities.
- Responsible for review of the change controls.
- Responsible for following cGLP/cGMP compliance in the AMV Laboratory and maintenance of Document cell.
- Responsible for following positive documentation practice and general cleanliness in the AMV laboratory.

Mpharm or MSc

📌 Senior Research Associate (India)
🏢 Aveva Drug Delivery Systems
📍 India