Investigation writer

Conduct detailed technical investigations using formal root cause analysis tools (e.g., 5 Whys, 6M methodology) Collaborate with cross-functional/site teams to gather and analyze investigation data Prepare clear, concise investigation reports and present findings to the Deviation Review Board. Initiate, track, and manage CAPAs within the Veeva QMS system Handle document-related activities including document changes, approvals, and compliance tracking Ensure all investigations and documentation comply with GMP, GDP, and CFR 21 (Parts 210 & 211) regulations Maintain high-quality standards in investigation writing and reporting Preferred Background 7–8 years of experience in Medical Device or Injectables industry Strong hands‑on experience with Veeva QMS and investigation processes #J-18808-Ljbffr