Sachbearbeiter Qualitätsdokumentation (m/w/d), Neumarkt
Core
Create specifications and analysis certificates for raw materials, packaging, and finished products; coordinate quality management processes in GMP-regulated pharmaceutical production.
Role type
Quality Documentation Specialist
Builds
Documentation for regulatory submissions and supplier/region-specific raw material batch records
Domain
Pharmaceutical industry, Quality Management (GMP)
Required skills
GMP compliance, Change Control management, defect complaint handling, data analysis for regulatory suitability, documentation preparation
Preferred skills
SAP, LIMS, MS Office
Responsibilities
Create specifications and analysis certificates for raw materials, packaging, and finished products; coordinate and administratively process QM processes like Change Controls; handle quality-relevant incidents such as defect complaints; prepare and compile analysis results for regulatory approval procedures; create documentation for country-specific and supplier raw material batch records
Seniority
Mid-level, specialized IC