Qi Chen

Actively looking for full time job in Pharmaceutical Industry specifically in Validation, Quality Control or R & D department. Current master student at Stevens Institute of Technology, will be graduated in Dec.2016. Possessing strong regulatory background includes knowledge of ICH Guideline, Current FDA regulations, cGMP guideline, Analytical Method Validation, Implementation and execution of IQ/OQ/PQ protocol, SOPs, CIP/SIP, Documentation, Deviation and change control, FAT, SAT, QbD, URS, Facility design, 21 CFR part 201,211, 11 and 810. Sterilization method, Quality Control, Regulatory compliance, Validation Master Plan, and Manufacturing and packaging of OSD. During the time in Stevens, I have learned how to apply various skills including but not limited to: root cause analysis, CAPA investigation, FMEA, lean thinking and Six Sigma methodology, PAT tools, and total quality management tools.