Meng Han

-Risk based quality oversight of bulk drug product manufactured by external CMO -Evaluation of distribution deviations (temperature excursions and transport issues) including creation of annual trend report about distribution deviations -Issue Management (Evaluation and report of drug product technical complaints; Negotiation of QAAs and QP agreements for IIR studies; Preparation and report of product quality escalation calls) -Qualification of primary packaging materials used for clinical studies ph. I-III

-Risk based quality oversight of bulk drug product manufactured by external CMO -Evaluation of transport deviations (temperature excursions and transport issues) including improvement of evaluation process using digital tools -Negotiation of SOPs -Negotiation of TRDs -Evaluation and report of drug product technical complaints (PTC) -Qualification of primary packaging materials used for clinical studies ph. I-III -Support IIR contracts/ QP-to-QP Agreements

-Product quality oversight with main focus on Eylea and its components -Assure regulatory and cGMP compliance with approved dossiers and with all relevant quality guidelines -Investigate deviations and drive CAPA investigations -Participation in quality teams and cross-functional teams including external suppliers

-Review and approval of SOPs und ensure the continuous improvement of the SOP-system -Improve the systems for Deviations, OOS and CAPAs -Create and review the test instructions and the qualification/ validation documents -Planning, performance and reporting for the internal and external inspections -Check of raw data -Training for employee and ensure the continuous updating of the training system

-Continuously update the quality management manual (QMH) and the site master file (SMF) -Review and approval of SOPs and ensure the continuous improvement of the SOP-system -Planning, performance and reporting for the internal and external inspections -Improve the systems for Deviations, OOS and CAPAs -Organize and coordinate qualification and validation activities -Continuous updating of the training system -Participation in internal quality Meetings -Leading and managing group of quality management

Mitarbeiterin Qualitätskontrolle für Fertigarzneimittel

Pharmatechnik