Senior Research Associate

Aveva Drug Delivery Systems Inc

0 years

0 Lacs

india

Posted:1 day ago| Platform: GlassDoor logo

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Skills Required

research verification analysis risk assessment report calibration spectrophotometer content reports reporting compliance maintenance documentation

Work Mode

On-site

Job Type

Part Time

Job Description

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.

Mpharm or MSc

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