● Provide Quality support to achieve the pMDI project milestones.
● Responsible for ensuring compliance with GMP requirements during the design, construction, start-up, validation (entire life-cycle) of Qingdao capital project initiative.
● Ensuring GMP compliance and operational effectiveness of the validation program (facility, equipment, utility qualifications; computer system validation, cleaning validation or process validation).
● Supervise and oversight contractors and intern activities as required
● Provide Quality expertise to the project and later site.
● Influence site management and propose solution options to improve and/or resolve technical challenges.
● Support development of GPQS, ECMS, GVLMS database and provide oversight and expertise.
● Provide oversight / ownership of QMS including validation, change controls, deviations, and related infrastructure activities.
