Senior Research Associate

• 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 good documentation practice and general cleanliness in the AMV laboratory.

Qualifications

Mpharm or MSc