About the job
Core
Operate QA systems for deviation and change control, ensure data integrity, and manage GMP upgrade projects in a pharmaceutical manufacturing environment.
Role type
Senior Quality Assurance System Manager
Builds
Robust QA systems, compliant documentation, and optimized contamination control strategies
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP project management, data integrity assurance, contamination control strategy (CCS) development, raw material management, supplier qualification and auditing, audit response coordination
Preferred skills
US FDA PLI and EU inspection experience, QC system expertise, analytical chemistry/microbiology lab experience, AMV experience
Technologies
GMP systems, QC software, lab information management systems
Responsibilities
Manage deviation and change control systems, upgrade documentation regulations, conduct quality compliance training, improve lab operations, establish contamination control strategies, evaluate raw materials and suppliers, lead GMP upgrade projects, respond to government and customer audits
Seniority
Senior, hands-on IC