Position Overview
Roles and Responsibilities:
Supports activities and initiatives of the quality organization to implement and manage the quality risk management activities as well as leading different QRM related job tasks.
This role will document evaluations relevant to commercial product risk for biologic drug substances, general site risk, risk associated with cross contamination, facilities, utilities and equipment risk as relevant to assigned responsibilities. Working knowledge of ICHQ, and Annex helpful.
The primary responsibilities will be collaborating with technical experts to update risk management documentation and ensure timely periodic review of risk documents and assist in revision when appropriate.
Provide project support to the Cross Functional Team and help to facilitate risk documentation as needed for projects related to risk, continuous improvement, or investigations.
Monitor and track open action items from the qual...