Mitarbeiter Qualifizierung/CSV (m/w/d)
Core
Support qualification of production equipment and systems and ensure compliance with GMP requirements in pharmaceutical manufacturing.
Role type
Quality Assurance / Qualification Engineer
Builds
Qualification plans, reports, risk analyses, and compliance documentation for pharmaceutical production equipment.
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP compliance knowledge, User Requirement Specifications (URS) creation, risk analysis (FMEA), qualification planning, SOP development, deviation reporting, change control, CAPA management
Preferred skills
Pharmaceutical engineering or chemical engineering degree, experience in pharmaceutical production, MS Office proficiency
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 trail reviews, update Standard Operating Procedures (SOPs), manage deviations and change controls, participate in internal/external audits and inspections
Seniority
Mid-level, hands-on IC
