Quality Assurance Engineer (Temporary 12 months) Visa Required
Core
Manufacturing Quality Assurance functions including deviation resolution, product impact analysis, CAPA, SOP approval, calibration oversight, and cGMP compliance.
Role type
Manufacturing Quality Assurance Engineer
Builds
Manufacturing plant operations compliant with cGMP and company policy
Domain
Pharmaceutical manufacturing (API, Bulk Drug, Finished goods)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
deviation resolution, product impact analysis, CAPA management, SOP approval, calibration program oversight, validation protocol authoring, batch release, quality plan development, FMEA, statistical quality programs, process monitoring
Preferred skills
knowledge of API/Bulk Drug/Finished goods regulations, risk analysis
Technologies
cGMP systems, CAPA systems, validation documentation tools
Responsibilities
Implement and maintain effectiveness of the Quality System; ensure quality goals and regulatory compliance; investigate plant events and perform product impact analyses; approve SOPs and calibration requests; audit commissioning and validation documentation; develop product quality plans, specifications, and risk analyses; participate in Validation Review Board.
Seniority
Mid-Senior, hands-on IC
