Mitarbeiter Qualifizierung/CSV (m/w/d)
Core
Ensuring compliance and qualification of production equipment and systems in pharmaceutical manufacturing.
Role type
Quality Assurance / Compliance Engineer (Pharmaceutical Production)
Builds
Qualified and compliant pharmaceutical production lines and systems
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP compliance, Qualification and Requalification (IQ/OQ/PQ), User Requirement Specifications (URS), Risk Analysis (FMEA), SOP creation, Deviation/Change Control/CAPA management, Audit preparation
Preferred skills
Pharmaceutical engineering or chemical engineering degree, Technical training (Pharmakant/Chemikant), Experience with filling systems, water/air systems, autoclaves
Technologies
MS Office
Responsibilities
Create URS and conduct risk analyses, Plan and execute qualification/requalification measures, Create periodic evaluations and audit trail reviews, Develop and update SOPs, Manage deviations and change controls, Participate in internal/external audits
Seniority
Mid-level, hands-on IC
