Global Change Control Clerk for EPD_Temporary Contract
Abbott
Rome, Italy
14 gg fa

JOB DESCRIPTION :

For EPD Dovision we are looking for a

Global Change Control Clerk

Primary Job Function

This position is responsible for performing the EPD Global Documentation Center activities for creation and maintenance of EPD Global Quality system and product related documentation in the EPD Global Documentation management system, as well as implementing and maintaining the EPD Global Change Control process.

Core Job Responsibilities

  • Understand and follow the applicable EPD Divisional policies / procedures and EPD GCCD departmental procedures.
  • Responsible of the management of Global / Divisional EPD documentation, by supporting the requests for creation or changes to documents, processing the Global change request in the EPD global documentation management system, and ensuring documentation compliance with corporate and EPD Quality System documents.
  • Serve as reference point and subject matter expert for the EPD Regional Doc Centers, EPD Divisional QA and non QA organizations, for topics related to document processing.
  • Responsible for the implementation of the Regulatory Approval Notification from the Regulatory Agency into the appropriate Quality Global / Divisional EPD documentation.
  • Responsible to provide guidance and assistant to all EPD on the Documentation management and Change Control process and systems used by EPD.
  • Responsible of the maintenance and Control of the documents for EPD Global Quality System, Global Region and Global Departments, in conjunction with the appropriate personnel and functions.
  • Education Required

    Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical / scientific area.

    Minimum Experience / Knowledge Required

  • GMP compliance knowledge in documentation and change control field
  • Knowledge of Microsoft Office Suite, Adobe Acrobat, Visio. System experience preferred using Electronic Document Management System.
  • Fluent in English
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