Quality Assurance Engineer (Temporary)
Core
Manufacturing Quality Assurance functions including resolution of deviations, product impact analysis, corrective and preventive action, and oversight of plant calibration and cGMP compliance.
Role type
Manufacturing Quality Assurance Engineer
Builds
Quality systems, product quality plans, specifications, and compliance documentation for manufacturing plants.
Domain
Pharmaceutical manufacturing (API, Bulk Drug, Finished goods)
Required skills
Quality system implementation, deviation resolution, CAPA management, product impact analysis, SOP approval, calibration oversight, validation auditing, risk analysis, FMEA, statistical quality programs, batch release
Preferred skills
Knowledge of regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
Technologies
cGMP, CAPA, FMEA, validation protocols
Responsibilities
Implement and maintain the effectiveness of the Quality System; ensure quality goals are met and practices comply with policies; conduct investigations and perform product impact analyses; approve SOPs and calibration requests; audit commissioning and validation documentation; develop product quality plans and risk analyses; participate on the Validation Review Board.
Seniority
Mid-Senior level (6+ years experience)
