Quality Assurance Specialist
Core
Ensure quality compliance and product release for sterile pharmaceutical products and manage external supplier quality within the Global Capability Center.
Role type
Senior Quality Assurance Specialist (Medical Device/Pharma)
Builds
Sterile biological drugs, terminally sterilized, and aseptically filled products for global distribution
Domain
Medical Device / Pharmaceutical / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
complaint management, deviation management, change control, CAPA, risk management, sterile production oversight, cGMP compliance, ISO13485/MDR regulatory knowledge, audit support, documentation management
Preferred skills
supply agreement review, quality agreement management, leading regulatory inspections, problem-solving
Technologies
cGMP, FDA regulations, ISO13485, MDR
Responsibilities
Manage complaint management processes; execute product release activities; provide QA oversight for sterile manufacturing; manage quality documentation; support internal/external audits and supplier due diligence; drive continuous improvement initiatives
Seniority
Senior, hands-on IC