Senior Specialist, Quality Control
Core
Quality control specialist supporting the design, construction, and validation lifecycle of a new pMDI manufacturing facility in China.
Role type
Senior Specialist, Quality Control (Facility Validation & GMP Compliance)
Builds
New pMDI manufacturing facility in Qingdao, China
Domain
Pharmaceutical manufacturing / Biotechnology / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Validation lifecycle management, China legislation knowledge, Quality Systems, Cross-functional collaboration, Technical mentoring, Contractor supervision
Preferred skills
Stakeholder influence, Complex problem solving, Active communication
Technologies
Computer system validation, Cleaning validation, Process validation
Responsibilities
Provide quality support to achieve project milestones; Ensure GMP compliance during design, construction, and validation; Participate in cross-functional interactions; Mentor and train QC and engineering staff; Supervise contractors and intern activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
