Must include some experience withbr Writing, reviewing, and approving scientific documents such as analytical test methods, analytical method validation data, protocols, and reports.br Technical guidance on method development, validation, and documentation to junior Analytical RD scientistsbr Reviewing quality control documents of raw material, intermediate, finished products, stability, reference standards qualification analyses, and instrument qualification data.br Writing and reviewing annual product quality report, and change control for SOPs, test methods.br Internal and regulatory audit, and out of specification OOS and Laboratory LIR investigations.br GMP, GLP, USP, and ICH guidelines and regulations.
Categories: eb3
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