Training and Documentation Specialist
Core
Develop and deliver GMP training programs and manage the GxP documentation lifecycle for a highly digitalized vaccine and biologics production facility.
Role type
Training and Documentation Specialist (GxP/QMS)
Builds
GMP-compliant training curricula, learning management system (iLearn) content, and lean regulatory documentation packages.
Domain
Pharmaceutical manufacturing / Biologics production / Quality Management Systems
Required skills
GMP compliance knowledge, GxP documentation lifecycle management, LMS administration, training program development, regulatory audit support, data analysis, change control processes
Preferred skills
Digital 4.0 concepts familiarity, GDPR compliance knowledge, QMS process contribution (Deviation, CAPA, Change Control)
Technologies
iLearn, AGVs, cobots, cloud systems
Responsibilities
Develop and implement annual GMP training programs; Administer the iLearn learning management system; Manage the GxP documentation lifecycle; Support audits and inspections; Contribute to QMS processes (Deviation, CAPA, Change Control); Evaluate training effectiveness.
Seniority
Mid-level, hands-on IC