Senior Expert Qualification (w/m/d)
Core
Lead GMP-compliant qualification of equipment, facilities, and systems, ensuring only qualified and functional systems are used at the site.
Role type
Senior Expert Qualification (Quality Specialist)
Builds
Qualified and functional systems for GMP-regulated production
Domain
Pharmaceutical manufacturing / Quality Management
Required skills
GMP qualification of equipment/facilities/systems, QMP/VMP management, SOP development and maintenance, data integrity regulations, technical system assessment
Preferred skills
Master's degree in natural sciences, project participation, change management assessment
Technologies
GMP, QMP, VMP, SOP, PQR
Responsibilities
Manage and ensure GMP-compliant qualification of devices, installations, rooms, and systems; Review, update, and approve QMPs, VMPs, and qualification documents; Ensure use of only qualified and functional systems; Define and develop qualification standards; Create, review, and maintain SOPs; Provide expert leadership and site-wide consultation for qualifications; Participate in projects and PQR evaluations
Seniority
Senior, hands-on IC
