The Role:
Our client is a global leader in Medical Device Manufacturing seeking a highly organised and detail-oriented Document Controller to support the construction of their large-scale manufacturing facility project in Galway. The successful candidate will be responsible for managing and controlling project documentation, ensuring compliance with regulatory requirements, and maintaining accurate records throughout the project lifecycle.
Key Responsibilities:
* Document Management: Organise, maintain, and control all project-related documentation, including design drawings, specifications, validation records, and change requests.
* Compliance & Quality Assurance: Ensure all documentation aligns with GMP, FDA, ISO 13485, and internal quality standards.
* Version Control: Implement document control procedures, track revisions, and ensure stakeholders have access to the latest versions.
* Collaboration: Work closely with engineering, construction, and validation teams to manage documentation workflows efficiently.
* Audit Readiness: Ensure document traceability and accessibility for internal and external audits.
* System Maintenance: Manage electronic document management systems (EDMS) and ensure data integrity.
* Training & Support: Provide guidance to project teams on document control procedures and best practices.
Requirements:
* Previous experience in a Document Controller role within a Greenfield project or the Construction industries.
* Familiarity with Good Documentation Practices (GDP) and industry regulations (GMP, FDA, ISO 13485).
* Experience working with Electronic Document Management Systems (EDMS).
* Strong organizational and administrative skills with high attention to detail.
* Ability to work under pressure and manage multiple tasks in a fast-paced project environment.
* Excellent communication and interpersonal skills.
#J-18808-Ljbffr