QA Associate Director

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From AstraZeneca’s original posting

Location： Qingdao Site This is a role as the principal quality assurance engineer in the leading edge project of new pMDI manufacturing facility in China. The role incumbent will • 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). • Cross functional interaction with both internal and external colleagues in Operations and Quality to ensure full compliance with AZ standards and local regulations. • Design and lead the automation digital processes to support QA business. • Mentor, train, and develop QA and other engineering / operations staff and interns in relevant technical subjects and is a key contributor to GMP training activities. • Supervise and oversight contractors and intern activities as required The incumbent has expert level understanding of China legislation, cGMPs, Validation and Quality…