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Document Controller

Posted 11 days 13 hours ago by Next Generation Recruitment

Permanent
Full Time
Other
Dublin, Ireland
Job Description

Step into a pivotal client-side role where your expertise in pharmaceutical documentation drives the success of cutting edge projects in Ireland's thriving life sciences sector.

Key Responsibilities
  • Client side control of all project documentation across the full lifecycle
  • Manage document receipt, review, approval, issue, revision control and archiving
  • Interface with EPCM partners, vendors, contractors and internal stakeholders
  • Ensure documentation complies with GMP, data integrity and ALCOA+ principles
  • Maintain accurate document registers, trackers and status reports
  • Support CQV documentation, executed protocols and final turnover to operations
  • Support audits, inspections and project close out activities
Essential Experience & Requirements
  • Proven experience as a Document Controller on pharmaceutical or life sciences capital projects
  • Essential: hands on experience using EIDA for document management
  • Experience working client-side or within an owner's project team
  • Strong understanding of GMP documentation requirements
  • Experience supporting construction, commissioning and qualification documentation
  • Ability to work full time on a live pharmaceutical site in Ireland
  • Experience on large scale Irish pharma projects (drug product, biologics, sterile facilities)
  • Familiarity with ValGenesis, Kneat, ACC or similar platforms
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