Literature search related to the drug substance, create analytical profiles.
Develop suitable analytical method for drug substance or drug product if not in Pharmacopoeia
To carry out characterization of the API and conduct pre-formulation studies as planned by the formulator
To conduct analysis of development samples as received from formulator and provide them with analytical report in the defined timeline.
To conduct calibration of allotted equipment with proper documentation and maintain the equipment in good condition. To follow the SOP of usage and document in the log books.
To conduct analysis of stability samples and prepare stability reports.
To validate the method developed and prepare validation report
Perform Lab to lab or Technology transfer of analytical method to the transferring site.
Prepare all documents related to Tech Pack for commercial transfer of the method.
Maintain lab notebooks in proper condition and keep it updated at all times.
To use PPE and follow safe practices in lab.