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On behalf of its Client, Kenny-Whelan is hiring a Document Controller - Quality, for one of its Global Life Sciences Companies in Limerick.
Profile of the Role:
The Document Controller will be responsible for Electronic Documentation and Records Management, as well as the execution, maintenance, and administration of Document Management Systems.
Description of Duties:
1. The Document Controller will assist in the initial program start-up and routine site operations, supporting site inspection readiness and execution.
2. Support document and records management program execution, including:
* Document management including metadata
* Revision and change control
* Quality systems support
* Audit support
* Records management
1. Maintain documents and records in the Electronic Management System, ensuring content is prioritized and kept up to date.
2. Ensure compliance with global and local documentation and records management requirements.
3. Establish and modify documentation to ensure accuracy and prevent errors, product recalls, or issues.
4. Manage document workflows from initiation to approval.
5. Monitor and manage assigned workflows daily.
6. Review incoming documents for completeness and alignment with GDP, supporting initial review for end-users.
7. Keep technical documentation up to date with support from technical team members.
8. Assist in generating reports on document workflows.
9. Collaborate with cross-functional departments to review documents and assign metadata.
10. Manage GMP-related record retention according to document type and record class.
Additional responsibilities include:
* Monitoring review comment backlogs, organizing large document review meetings.
* Providing training on document control interfaces.
* Supporting site self-inspections related to Document Control and the Electronic Management System.
Note: The above list is not exhaustive.
Experience and Requirements:
- 3 to 4 years of experience as a Document Controller, preferably with Quality experience, within the Pharma/Biotech industry.
- Experience in creating prototype implementations for testing documentation accuracy and effectiveness is preferred but not essential.
IT Systems:
* Proficiency in MS Office Suite (advanced level).
Important: This is an onsite role, Monday to Friday.
All applications will be treated with the strictest confidence.
Kenny-Whelan Contact:
For further information, please send your updated CV to us.
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