Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative
Job Summary
Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative.
Responsible for ensuring GMP compliance and operational effectiveness of the validation program, including facility, equipment, utility qualifications, and computer system validation.
Design and lead automation digital processes to support QA business, mentor and train staff, and supervise contractor activities.
Matching Summary
Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative.
Skills & Requirements
Must-have
GMP compliance
validation program
Quality Systems
China legislation
cGMPs
deviations and change controls
Nice-to-have
automation digital processes
influencing stakeholders
cross functional interaction
operational effectiveness
Key Requirements
Expert level understanding of China legislation, cGMPs, Validation and Quality Systems
Experience with deviations and change controls
Ability to influence stakeholders and make quality assurance decisions