We're looking for a skilled professional to support the quality and compliance of our operations.
About the Role:
The Audit and Inspection Management professional will play a crucial role in ensuring the quality and compliance of our operations by providing support, oversight, and education to quality and business personnel.
Main Responsibilities:
* Provide support, monitoring, and education to quality and business personnel for assigned quality system components, including Audits and Inspections.
* Collaborate with process owners to monitor and continuously improve processes.
* Serve as a SharePoint Site Administrator (MIM sites) to develop and manage inspection management infrastructure for logistics, preparation/planning, and close-out activities.
* Manage the archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections.
Requirements:
* Bachelor's degree
* Experience in Inspection/Audit preparation within a GCP/GLP/GPvP environment
* Proficiency in IT/systems supporting quality, specifically TrackWise, OneQMS, Notification to Management, SharePoint, and Power BI
* Familiarity with GLP, GCP, and GVP global regulations as they relate to Clinical Development, Drug Safety, and Drug Development