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Document Control Specialist

Document Control Specialist

ConfidentialIndia
14 hours ago
Job description

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 documents
  • Provide 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

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    Document Specialist • India

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