Document Standards Specialist

9 hours ago

Tralee, Co Kerry, Ireland beBeeDocumentController Full time €45,000 - €60,000
Job Overview

We are seeking a skilled Document Controller to oversee the creation and management of controlled documents that meet our site and regulatory standards. This is an exciting opportunity for a detail-oriented professional to join our team.

Key Responsibilities:
  • Review and approve controlled documents across multiple systems, ensuring compliance with formatting, numbering, and metadata requirements.
  • Collaborate with authors, reviewers, and approvers to ensure consistency across all training and operational documents.
  • Validate document metadata (author, version, effective date, approvals) for accuracy and completeness.
  • Participate in internal and external audits/inspections, providing evidence of document compliance and technical integrity.
Required Skills and Qualifications:
  • Bachelor's degree in a scientific or technical discipline.
  • 2+ years' experience in QA Document Control or a related quality function in a regulated environment.
  • Strong knowledge of GxP regulations, FDA/ICH guidance, and GMP best practices.
  • Experience with EDMS and familiarity with ValGenesis and RMS.
  • Detail-oriented, organized, and able to manage multiple priorities under deadlines.

This is a unique opportunity to join our organization as we establish a new manufacturing plant. As a Quality Assurance Document Controller, you will play a critical role in setting up and maintaining document standards and compliance processes from the ground up.

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