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/process/cleaning validation.
Design and lead automation digital processes to support QA business, mentor and train staff, and supervise contractors and interns.
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 operational effectiveness
Cross functional interaction
Automation digital processes
China legislation cGMPs
Quality Systems deviations change controls
Nice-to-have
Influencing stakeholders and partners
Active communication with colleagues
Mentoring and training staff
Embraces diversity and equality
Key Requirements
Expert level understanding of China legislation
Expert level understanding of cGMPs
Expert level understanding of Validation
Expert level understanding of Quality Systems
Expert level understanding of deviations and change controls
Current knowledge of regulatory and industry trends