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Document Controller

  1. West
County Limerick
  1. Contract
Competitive
  1. Life Sciences
03-04-2024
33809WP
Document Controller - QA - Bio-Pharmaceutical - 12-Month Contract

An exciting opportunity has arisen for an experience Document Controller to be part of a new build project.

Working within the QA department you will be involved in the document control start-up and routine operation of the document and records management program.

This will relate to:
    • Document management including meta-data
    • Revision and Change control
    • Quality Systems support
    • Audit support
    • Records Management
In addition to this you will be responsible for th electronic documentation and records management oversight working on the execution, maintenance, and administration of document management systems.


Duties will involve:
  • Maintain all documents and records maintained in the relevant Electronic Management System, ensuring content is prioritised kept up to date 
  • Ensure compliance to Global and Local Documentation and Records Management requirements. 
  • Establish new and modify existing documentation to a high standard to avoid product recalls or issues.
  • Manage the flow of documents from initiation of work-flow to approval.
  • Review and accept incoming documents are complete and aligned with GDP, support initial review of documentation for end-users.
  • Ensure that technical documentation is kept up to date with the support of technical team members for the creation of content 
  • Provide training to appropriate personnel on doc control interfaces.
  • Support external and internal audits through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and auditing and compliance groups. 
  • Support Site Self Inspections associated with Document Control & the Electronic Management System.  

Skills & Experience:
  • Excellent Document control experience ideally within a pharmaceutical / Bio-pharmaceutical environment
  • Experience with document management processes 
  • Experience within administration function, supporting and coordinating within large organisations/teams
  • Experience in the use of Microsoft Office programs and other relevant software programs
  • Fluency in English both writing and speaking 
  • Excellent communication skills to work with other teams
  • Detail-focused document organising abilities.  Excellent attention to detail.
  • Flexible and able to adjust strategies to changes in the environment

If this role is of interest to you, please apply now! 

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