OVERALL RESPONSIBILITIES :
- Accountable for administration of the Windchill change process.
- Accountable for compliance with the Food and Drug Administration's (FDA) Quality System Regulation (QSR) as it pertains to Documentation and Documentation Control.
- Coordinate project activities and maintain timelines
- Provide project tracking, reporting, and communications
- Accountable for the timely processing and release of new and changed controlled documents.
- Proficient with Microsoft office : Word, Excel, and PowerPoint
POSITION DUTIES & RESPONSIBILITIES :
Accountable that Change Requests and Change Notices(CRs / CNs) are reviewed for completeness, accuracy and compliance with applicable policies and procedures.Coordinate workflow and DePuy Synthes priorities of Document Management with team management and Change Owners on an as needed basis.Communicate change status information as requested.Support the Periodic Review process for controlled Quality documentsProvide historical and current documentation in response to queries from management and other departments as needed.Properly employ all SOPs, Work Instructions, Training Guides, and Forms in the performance of tasks.Perform other special projects and support functions as assigned by the Manager and / or Supervisor of Document Management.Skills Required
Windchill