Spezialist Qualifizierung Pharmazeutischer Anlagen (w/m/d)
Core
Qualification of pharmaceutical equipment, processes, and sterilization/cleaning procedures to ensure quality standards in production.
Role type
Specialist in pharmaceutical equipment qualification
Builds
Pharmaceutical production facilities and processes
Domain
Biopharmaceuticals / Manufacturing
Required skills
Technical or natural science education, Quality management, Project management, Risk assessment, Documentation creation, Regulatory knowledge
Preferred skills
Experience in pharma/chemical/technical industry, Communication skills, Structured problem-solving
Technologies
GMP, Validation protocols, Risk assessment tools
Responsibilities
Plan, execute, and coordinate qualification activities for production equipment and processes; Create and review qualification documentation (test plans, protocols, reports); Conduct operational qualification activities (e.g., temperature studies); Participate in interdisciplinary project teams for implementation and optimization; Support internal and external audits.
