Perform the Quality System Monitoring Report used in the Management Review Process. * Generates KPI metric data and completes data analytics in support of process performance and improvement. * Expert knowledge of applicable regulations, quality principles, business processes, and techniques. * Minimum 10 years in pharmaceutical/biologics industry in Quality Assurance, including Biopharmaceuticals/Advanced Therapies. * In-depth understanding of Health Authority compliance expectations for reporting quality-related issues (GMP, Clinical). * Proficient in Excel, data analytics, and eQMS tools for deviations, CAPAs, audits, and KPI reporting.
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