Chemieingenieur (m/w/d)
Core
Ensuring compliance and qualification of pharmaceutical production systems and equipment.
Role type
Senior Quality Assurance Engineer (Qualification/CSV)
Builds
Qualified and compliant pharmaceutical production lines and systems
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP compliance, Qualification & Requalification, Risk Analysis (FMEA), URS creation, SOP development, CAPA management, Audit support, Periodic reviews
Preferred skills
Pharmaceutical production experience, Technical training (Techniker), MS Office
Technologies
MS Office
Responsibilities
Create User Requirement Specifications (URS), Conduct and document risk analyses, Plan and execute qualification/requalification measures, Create periodic evaluations and audit trails, Develop and update SOPs, Manage deviation reports and CAPAs, Participate in internal/external audits
