Quality Review Specialist (GMP / Batch Record / DHR) (m/w/d), befristet
Core
Reviewing GMP-compliant manufacturing and production documentation (Batch Records, Device History Records) to ensure product quality and patient safety in the IVD sector.
Role type
Quality Review Specialist (GMP / Batch Record / DHR)
Builds
Production-ready batch records and device history records for in-vitro diagnostic devices
Domain
Life Sciences / In-Vitro Diagnostics (IVD) / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance knowledge, ISO 13485 knowledge, Batch Record review, DHR review, deviation management, SOP creation/maintenance, data analysis in Excel, document archiving, training administration
Preferred skills
Experience in IVD, medical device, or pharma regulated environments
Technologies
Excel, Outlook, Word
Responsibilities
Conduct Batch Record and DHR reviews per GMP and ISO 13485 requirements; Ensure completeness and compliance of manufacturing documentation; Create and release Batch Records for production; Identify, evaluate, and track deviations; Assist in creating and maintaining SOPs and GMP documents; Collaborate with Production, Quality Assurance, and Management; Support internal and external inspections and audits; Contribute to continuous improvement of review processes; Manage document archiving and qualification activities; Track documentation error metrics and drive improvement measures; Manage training documentation and implementation of new manufacturing documents
Seniority
Mid-level, hands-on IC
