QA Manager, Compliance, Data- & Business Analysis
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1SOP and Work Instruction - Creation/Remediation2Development of Training Materials &
• Audit Checklists3Technical Documentation Support (DHF, DMR, DHR)4Business Process Analysis &
• Optimization5Specification &
Requirements Documentation6CSV, Qualification, Process &
• Method Validation7Test Management8CAPA Management, Root Cause &
• Risk Analysis, Riskmgmt.9Request, Change &
• Configuration Management10Incident, Problem &
• Workflow Management11Material &
• Equipment Management12Electronic Documentation: eLogbooks, eBatch Records13Information Integration and data aggregation
