Engineer, QA
Core
Ensure GMP compliance and operational effectiveness for the pMDI project lifecycle (design, construction, start-up, validation) and Qingdao site QMS establishment.
Role type
Senior IC Quality Assurance Engineer (Pharmaceutical Manufacturing)
Builds
GMP-compliant facility and equipment systems, validation programs, and QMS infrastructure for the Qingdao site.
Domain
Pharmaceutical manufacturing / Quality Assurance / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance knowledge, validation program management, QMS implementation, change control, deviation management, 21 CFR 11 basics, cross-functional collaboration, GMP training delivery
Preferred skills
Computer validation expertise, pharmacopeia knowledge, digitalization and autonomy project experience, continuous improvement methodologies
Technologies
GPQS, ECMS, GVLMS databases
Responsibilities
Provide quality support to achieve pMDI project milestones; Ensure GMP compliance during design, construction, and start-up phases; Support development of QMS including validation, change controls, and deviations; Interface with engineering, IT, QC, and manufacturing functions; Develop and drive departmental processes, documentation, and training; Support QA efforts for GMP-related facility and equipment systems.
Seniority
Mid-level, hands-on IC
