Everyone has his strengths and his preferences. We see this as a particular strength of our international team.
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Dr. Hartmut STEINEL
— General Manager
As the General Manager and founder of Shanghai Jinji, Dr. Steinel successfully leads the company and acts as one of the main scientific adviser to the manufacturers. He is also a well known leading auditor (with more than 300 audits in the last 10 years) and has a reputation for providing excellent insight into the Asian market quality. Having studied at the University in Ulm, Germany, and University of New South Wales, Australia, he worked in Cancer Research and published several articles on this topic.
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Mo Nianling
— Chief Engineer
Mr. Muo has working experience in the pharmaceutical industry for 42 years, he used to work as QC section manager and QA section manager in Shanghai Pharmaceutical, after that he worked in Green Valley as a chief engineer. Mr. Muo specializes in the exploration of process, the layout of Workshop, production process validation, analytical validation, utility and quality management systems.
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Juergen STEINEL
— Vice General Manager
Mr. QIAO has an extensive experience in Pharmaceutical GMP filed for 10 years. He used to work as GMP department manager in our company and has achieved many EU-GMP projects successfully. Thus, he is very familiar with the company’s operation process and is good at project management. At present, he is our vice general manager of our company and is still mainly responsible for GMP department and Audit department. Through training, he has gained much insightful understanding of the EU-GMP regulation. Besides he has also much experience in working as interpreter on site during the inspection of European Inspectors.
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Shane LI
— Head of GMP department
As the department leader of the GMP department, Ms Li is responsible for guiding and supervising all GMP projects. She has assisted and been in charge of many certification projects. She is familiar with the EU-GMP requirements about warehouse, production, laboratory and GMP-relateddocumentation. She has taken part in more than 20 on-site inspections conducted by the European inspectors, and has gained much inspection experience by working as interpreter in more than 10 on-site inspections. Due tothese projects and audits, she gained enough experience to meet the requirements of different clients. Besides, she is one of the main Chinese auditors recognized by the German authorities and she performed more than 50 audits as lead auditor. Before she worked for our company, she graduated from and worked for Shanghai Jiaotong University.
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Philipp ROTH
— Head of Audit Department
Mr. ROTH joined Shanghai Jinji in 2008 as Regulatory Affairs Manager and now heads our company’s Audit department. He ensures the quality of the audit program according to the requirements of ISO19011:2011 and is familiar with the requirements of EU GMP according the ICH guidelines. He is responsible for organizing the overall audit program and takes part in individual inspections of pharmaceutical manufactures. Taking part in about 50 audits per year, he supervises all auditors in our company. In the GMP programs, he is in charge of quality assurance and gives other auditors training.