Y an jiang

1, Hosting GMP inspections: I was responsible for hosting audits by regulatory bodies like NMPA, clients (e.g. Novartis, Pakistan client) and consultant agencies (e.g. NSF, former FDA investigators for Mock PAI inspection). Seven audits were organized in total. Audits duration varied from 4 days to 20 days. No critical defects were found during audits. We passed all GMP inspections by NMPA and by all clients. 2, Interpretation of FDA warning letter, and form 483 I was responsible for translating warning letters and form 483 issued by FDA every month, and include the bilingual version in the monthly Quality Report. I also selected pieces of form 483/ warning letters to share with colleagues from Production, facility and engineering on a biweekly webinar via Microsoft Teams meeting. A total of 26 warning letters and 483 were translated, and four lectures were given, which helped to improve the quality culture awareness throughout the facility. 3, Systematic improvement of data integrity 4, Documents translation: I was the translated and proofreader for files for the company's BLA project and IND purpose. 5, I was the assistant of Vice President (based in US), Global Quality for 6 months.

I was responsible for interpretation on lectures by government officials. Questions and answers also need to be consecutively translated. When the project ended, I was recognized by the official and got re-invited by the organization.

I was responsible for providing conference translation for Chairman of Great Wall International Congress of Cardiology, HRS President, ACC President, and others professors; Responsible for the registration of overseas presidium of academic department; Organize the contest hosted by ACC during the conference. My translation was recommended by the presidents of ACC, HRS and other organizations.