Ekspert upravljanja kakovosti – operacije (m/ž/d)
Core
Ensuring quality of production processes, from reviewing production documentation and batch release preparation to resolving deviations and approving changes for aseptic drug manufacturing.
Role type
Quality Management Operations Expert (GMP)
Builds
Aseptic drug production batches and innovative therapies
Domain
Pharmaceutical manufacturing / Aseptic production
Required skills
Good Manufacturing Practices (GMP), deviation investigation, change management, stakeholder management, process optimization, batch release preparation, regulatory compliance
Preferred skills
aseptic production environment experience
Technologies
Microsoft Office
Responsibilities
Review production documentation and prepare batches for release; Approve production records, master data, and specifications; Support production quality during packaging and assembly; Lead deviation investigations and corrective/preventive actions; Review and approve changes ensuring GMP compliance; Communicate with internal stakeholders and contract manufacturing organizations
Seniority
Mid-level, hands-on IC
