Production Event Investigator
Core
Authoring and overseeing the completion of deviations, investigations, CAPAs, and related reports for Commercial Operations to ensure GMP compliance.
Role type
Production Event Investigator (Quality)
Builds
Quality event investigations and CAPA implementation for oral solid dosage forms
Domain
Pharmaceutical manufacturing (oral solid dose)
Required skills
Root cause analysis, CAPA management, GMP compliance, technical writing, cross-functional collaboration
Preferred skills
Oral solid dosage forms experience, FDA cGMP knowledge, GDP experience, cGMP quality systems experience
Responsibilities
Own and manage quality events related to Commercial Operations, Packaging, Pharmaceutical Development, and minor laboratory investigations; Lead cross-functional teams to investigate complex quality events; Author deviation investigations within required timelines; Partner with functional areas to identify root causes and determine appropriate corrective and preventive actions; Initiate, document, and track corrective and preventive actions (CAPAs) to ensure timely implementation and effectiveness; Provide timely updates to management on the status of Good Manufacturing Practice (GMP)-related investigations; Monitor and ensure CAPA effectiveness checks are completed; Populate non-conformances to ensure records are factual, accurate, and properly investigated to determine probable root cause.
Seniority
Mid-level, hands-on IC