Master Data Manager GxP Systems (m/w/d)
Core
Ensures regulatory compliance of GxP-critical systems (LIMS, MES) and manages quality-relevant data flows, roles, permissions, and master data integrity.
Role type
QA Data Steward (GxP Systems)
Builds
GxP-compliant quality systems and data integrity controls for pharmaceutical operations
Domain
Pharmaceutical industry + GxP regulatory compliance
Required skills
GMP-regulated environment experience, LIMS/MES system knowledge, data integrity (ALCOA+) assessment, regulatory requirement translation, deviation/CAPA handling, audit preparation
Preferred skills
Master's degree in Pharmacy/Natural Sciences/CS/Data Science, experience in CSV/Digital Quality, analytical thinking (via careerplan.io/jobs/2744478-master-data-manager-gxp-systems-mwd-at-rottendorf-pharma-gmbh)
Technologies
LIMS, MES
Responsibilities
Ensure GxP-relevant processes in quality systems are correctly and compliantly mapped including data flows and interfaces; Evaluate system changes and interfaces for GMP and data integrity requirements; Define and verify quality requirements and controls for GxP-critical master data; Support handling of deviations, system-related CAPAs, and audit preparations; Act as interface between regulatory requirements and digital system landscape
