Senior Project Document Controller
Kenny-Whelan is hiring a Senior Project Document Controller for one of its Global Life Science Companies in Limerick.
Profile of the Role:
Responsible for Electronic Documentation and Records Management, as well as the Execution, Maintenance, and Administration of Document Management Systems.
Description of Duties:
• The Senior Document Controller will aid in start-up and routine operation of the document and records management program execution, specifically:
o Document management
o Revision and Change control
o Audit support
o Records Management
:
Maintain documents and records in the relevant Electronic Management System, ensuring that the right content is prioritized and kept up to date over time.
• Ensure compliance with Global and Local Documentation and Records Management requirements.
• Establish new and modify existing documentation to achieve accuracy and prevent errors, product recalls, or issues.
• Manage the flow of documents from initiation of workflow to approval.
• Day-to-day management and monitoring of assigned workflows.
• Review and accept incoming documents to ensure completeness and alignment with GDP, supporting initial review of documentation for end-users.
• Ensure technical documentation is up to date, with support from technical team members for content creation.
• Meet with cross-functional departments to review documents when adding them to the Electronic Management System.
• Manage Retention of GMP Related Records according to Document Type and Record Class Code.
• Support Site Self-Inspections associated with Document Control & the Electronic Management System.
*** This list is not exhaustive ***
Experience and Requirements:
- 5+ years of experience as a Document Controller, supporting senior management, preferably in the Pharma/Biotech industry.
- Relevant 3rd-level business/science qualification or other.
- Strong interpersonal skills and adaptability to frequent changes in priority.
- Ability to maintain accuracy.
- Manage urgent deadlines.
IT Systems:
• Advanced competency in MS Office Suite, Word, Excel, PowerPoint, Outlook
• EDMS experience
*** Please note this is an 'Onsite' role, Monday to Friday ***
All applications will be treated with the strictest confidence.