Iris W Email & Phone Number

China

Performing Supplier Qualification GMP audits of KSM/Intermediates/FDFs in China. Handling the the day to day operations at office and reporting to regional Head.

Hebei, China

• Establishing and maintaining the company's quality management system, supervising the system• Organizing internal audits of the quality management system• Organizing quality audits of various organizations and customers• Responsible for external supplier audits• Responsible for API and FPP registration submission and management• The management of GMP consulting projections• Working as a GMP inspection interpreter• Supporting in United Nations bidding projection

Hebei, China

• Leading and carrying out projects for international drug registration and GMP certification of FPP• Engaging in CTDs preparation, review and submission for oversea markets, mainly including PIC/S member counties, Japan, South Africa, Southeast Asia, Africa, Latin America and other countries• Organization of foreign authority GMP inspections and customer audits and GMP interpretation etc.

Hebei, China

• Responsible for international registration and certification of APIs • Responsible for the preparation, updating and submission of DMF and CEP documents• Responsible for foreign authorities GMP inspections and customer audits• Responsible for drafting validation master file, site mater file• Organizing EDQM site inspection • Drafting quality documents like VMP etc. • As Register Affairs representative, participating in Change control activities and providing comments from the RA’s point review • Participating in CAPA management, self-inspection, etc.