Document Control Specialist
SIRE
Noord-Brabant, The Netherlands
14 dagen geleden

The company

Our client is a professional organisation, based in Noord-Brabant Netherlands.

Role description

You will be a member of the support group of the Philips Document & Record management system. In your role you will :

  • Support lower level Document Control Specialists.
  • Controls & maintains the document management system for issuance recording / filing, tracking, retrieval of documents like procedures, plans, QA / QC records, Specifications and related documents.
  • Leads and supports (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel.
  • Responsibilities

  • Effective (local) Business Process Ownership / Expert role for Document Control processes and tools in scope
  • Establish Document Control support to authors and (local) process owners in defining and producing lean Quality System documents and records;
  • ensure proper quality of the content of documentation and records

  • Establish and manage proper document review processes
  • Ensures availability / publishing of controlled documents
  • Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
  • Requirements

  • 3 to 5 years related experience in change control and / or document control field
  • Familiarity with Document Management System tools
  • Experience running effective process improvement projects
  • Knowledge of FDA regulations and regulatory requirements
  • Preferred Qualifications :
  • oEngineering background.

    oPrior group or team leadership experience.

    oProcedural or Technical writing experience.

    oUnderstanding of modeling tools.

    oAwareness of Project Management Institute standards.

    Required competences :

  • Knowledge about Quality Management, Regulatory Management
  • Being a Q&R Business Partner
  • Able to support Computer Systems Validation
  • Able to work in a virtual environment
  • Advanced MS Office user (inclusive SharePoint Designer)
  • Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.

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