一、ARD Manager ---某美资制药公司
ARD Manager for a FDA/cGMP & sFDA/GMP-regulated pharmaceutical plant based in Suzhou, China.
Assist Analytical Services Director Responsible for project management. Responsible for Method Transfer/Verification/Validation, equipment specification and selection, procedure development, Analytical Services staff training and analytical based investigation of Operational and quality issues. Responsible for managing the day-to-day project samples, raw materials and finished products, stability samples test. Ensure projects conform to the necessary regulatory and GMP requirements
MS or PHD degree in Chemistry or related major
Experience in managing GMP projects and resources to develop, validate and transfer analytical methods, including HPLC, GC and other standard analytical techniques.
Good working knowledge of USFDA cGMP’s for raw material and pharmaceutical products. Good at searching literature and then designing analytical methods.
5-8 years working experience in generic pharma industry