Senior Associate, Quality Assurance – Data Steward (m/w/d)
Tasks
- Create manage quality master data in SAP
- Implement validate maintain computerized quality systems
- Lead mentor coach on quality systems
- Manage compliance documents specifications procedures
- Oversight of site master data establishment
- Participate in self inspections and support internal inspections
- Perform data identification and reviews
- Protect integrity and accuracy of quality data
- Review approve GMP documents
- Serve as QA power user for IT systems
- Support continuous improvement of quality systems
- Support deviation procedure protocol specification change control
- Support global quality network and global IT
- Support onboarding of new materials in TrackWise
- Support regulatory inspection activities with documentation and SME support
- Support site readiness planning
Perks/Benefits
Skills/Tech-stack
Batch Disposition | CGMP | Cause analysis | Change Control | Computerized Quality Systems | Data Management | Data Stewardship | Deviation Management | Deviation investigation | GMP | Inspection management | LIMS | Laboratory Specification Management | Manufacturing Execution System | Manufacturing execution | Master Data | Master Data Management | Materials Management | Method management | PharmaSuite | Procedure Management | Quality Systems | Quality management | Regulatory Compliance | Root Cause Analysis | Root cause | SAP | Specification Management | Technical writing | TrackWise | Validation | Veeva
Education
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