Quality Engineer – QA Equipment Qualification
Core
Ensure quality oversight for production equipment related to manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates during the multiyear Atlas capacity expansion project.
Role type
Staff Quality Engineer (Equipment Qualification)
Builds
New multipurpose installations including reactors, centrifuges, dryers, and filter dryers for SM-API and DP Intermediates manufacturing.
Domain
Pharmaceutical manufacturing / Chemical industry / Supply Chain Engineering
Required skills
Equipment Qualification, cGMP compliance, Risk analysis, Audit preparation, Change Controls, CAPA handling, Regulatory guidelines knowledge, Project lifecycle management
Preferred skills
GAMP, ISO 9001, Lean Supply Chain Management, Data Integrity Guidelines, Engineering, Financial Competence
Technologies
Reactors, Centrifuges, Dryers, Filter dryers, Utility systems
Responsibilities
Review and approve Qualification documents (SOPs, plans, tests, deviations), Maintain knowledge of international laws and guidelines, Prepare for and perform internal and external audits, Cooperate with engineering and operations teams, Ensure GMP Quality framework compliance for innovation projects
Seniority
Staff, hands-on IC
