Qualitätssicherungsmitarbeiter Quality Oversight / Batch Record Review (m/w/d)
Core
Reviewing batch records and manufacturing documentation to ensure GMP compliance for sterile injection systems.
Role type
Quality Assurance Specialist (Batch Record Review)
Builds
Sterile injection systems and other medical devices for pharmaceutical manufacturers
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
GMP compliance knowledge, batch record review, deviation analysis, CAPA coordination, regulatory documentation review, root cause analysis, change control management
Preferred skills
Aseptic manufacturing experience, TrackWise/Veeva proficiency, English language skills
Technologies
TrackWise, Veeva, MS Office
Responsibilities
Observe pharmaceutical manufacturing processes and document quality deviations, Review batch and maintenance documentation using checklists, Conduct AQL sampling and evaluate optical control results, Process quality events like deviations and CAPAs in Quality Management Tools, Approve cGMP documents and batch records, Analyze deviation causes and coordinate corrective actions
Seniority
Mid-level, hands-on IC
