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QMS Project Coordinator

NextLink Solutions

Posted on Apr 19, 2021 by NextLink Solutions

Barcelona, Spain
Immediate Start
Annual Salary

NextLink are currently working with a leading pharmaceutical organisation who are seeking a QMS Project Co-ordinator for their Barcelona offices on an initial 6-month contract.

The Role

  • Understand the regulatory framework for the different types of applications and procedures

  • Own the Project Documentation plan, follow up documentation completeness,

  • Manage documents life cycle Document management system, upload documents, manage and follow up workflow

  • Provide status update to stakeholders on documentation plan

  • Work with Quality team to define documentation plan for releases

  • Maintain project documentation updated in repositories

  • Ensure Documents follow quality standards of formatting and content

  • Extract and create documents from Jira

  • Lead/contribute to the planning, preparation of documents and delivery of submissions throughout the product's life cycle

  • Coordinate the input, maintenance, and revision in the Digital project plans for assigned projects

  • Identify regulatory risks on documents timeline and propose mitigations to Project Manager and teams.

  • Ensures monitoring and evaluation of generated documentation.

  • Collaborate in writing and updating end technical and functional documentation

Experience Required

  • Extensive Project management/coordination experience

  • Proven experience in Technical writing for software applications

  • Proven experience with Confluence, JIRA, Windchill

  • Familiarity with software development processes.

  • Fluent English and Spanish

  • Regulatory experience within the pharma/health industry would be a bonus

Reference: 1172164450

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