To develop and maintain Good Laboratory Practices (GLP).
To procure laboratory instruments and ensure their qualification.
To procure certified reference standards (CRS) and ensure their maintenance as per recommendation.
To procure glassware, chemicals, HPLC/GC columns, safety equipment, personnel protection kits of recommended grades and maintaining minimum inventory for smooth operation of quality control department.
To prepare and review standard operating procedure (SOPs), protocols, instrument usage logbooks for all analytical instruments in Analytical Development Laboratory.
To perform analysts qualification for all analysts and maintain their training record.
To perform and ensure calibration of all analytical instruments as per calibration schedule.
To support formulation team, to conduct pre-formulation studies.
To develop analytical methods and prepare the method development report.
To perform analytical method, transfer from ADL to Plant QC.
To ensure periodic self-inspection, internal audits of Analytical Development Laboratory.
To execute analytical method validation / verification as per guidelines.
To support regulatory team of providing all analytical data for their preparing and filing dossiers/ drug product registration with health regulators.
