Officer ADL ADL
Job Description
*Strong practical knowledge of HPLC method development and validation for assay and related substances of Active Pharmaceutical Ingredients (API).
*Experience in characterization of drug substances, including intermediates, in-process materials, stability samples, and unknown impurities (identification/confirmation).
*Preparation and review of SOPs, STPs, and specifications.
*Hands-on experience with analytical instruments such as Gas Chromatography (GC), UV Spectrophotometer, Auto Titrator, Karl Fischer, etc.
*Knowledge of ion chromatography for analysis of ionic impurities in drug substances.
*Preparation of technical documents and reports, including AMDR, protocols, justification reports, and analytical reports.
*Ensure adherence to GMP, SOPs, and EHS (Environment, Health & Safety) regulations.
*Transfer of developed analytical methods to the Quality Control (QC) department.
*Ensure all activities are properly executed, documented, and aligned with company policies and objectives.