Frankfurt, Hesse, Germany
I am a pharmacist (German approbation), born in China but raised in Germany. Speaking three languages fluently (German, Chinese, English) and holding a PhD in molecular pharmacology research, I am driven by my search for new challenges within the multidimensional sectors of the Pharmaceutical and Medical Devices industry. “Quality” and "Continuous Improvement" are the main focus of my professional journey. Over the years, I have gained valuable insights in Manufacturing, Quality Compliance and Auditing both in Pharmaceutics and Medical Devices. Being a curious person by nature and always on my quest for knowledge, I am eager to explore and connect to fellow professionals.
The main area of responsibility include: - Planning, Performance and Follow-Up of on-site audits at Fresenius Kabi organizations across the globe: a) Manufacturing sites according to Pharmaceutical (e.g. 21CFR, Eudralex, PIC/S) and Medical Device (e.g. ISO 13485, MDSAP) regulations and standards b) Distribution sites according to international standards (e.g. ISO 9001) and regulations (e.g. GDP) c) Vigilance units using international criteria (GVP) and internal requirements d) Research & Development Centres according to applicable standards and requirements - Establishment of global internal audit plan via risk-based approach - Performance of remote audits in accordance with applicable standards and regulations
The main area of responsibility included: - Planning, Performance and Follow-Up of audits at suppliers and contractors to ensure compliance of outsourced activities with applicable regulations and standards (e.g. Eudralex, ISO 15378) - Supplier Management: qualification and evaluation of external suppliers and service providers within the Supplier Lifecycle Management - Management and improvements of projects and / or processes to support departmental projects and objectives according to agreed timelines and standards
The main area of responsibility included: Manufacturing Quality: - Investigation of deviations, CAPA and Change Control management - Batch Record Review - Author and reviewer of documents, relevant to product quality (qualification, validation, process monitoring) - Support of inspections by Health Authorities, external and internal audits - Member of intercompany and external project teams related to GMP-relevant topics.
Representation, organization of seminars and programs
Research of bio-molecular aspects of major depression, with the target being the identification of protein interactions concerning the pathology. The methods included different cell cultures (immortalized & primary), Live Cell Imaging and Confocal fluorescence laser microscopy.