Document Controller Quality
On behalf of its Client, Kenny-Whelan is hiring a Document Controller Quality for one of its Global Life Sciences Companies in Limerick.
Contact: Carmel Synnott : csynnott@kenny-whelan.ie
Profile of the Role:
Responsible for electronic documentation and records management, as well as execution, maintenance, and administration of document management systems.
Description of Duties:
1. The Document Controller will assist in initial program start-up and routine site operations, supporting inspection readiness and execution.
2. The Document Controller will support the start-up and routine operation of the document and records management program, including:
- Document management including metadata
- Revision and change control
- Quality systems support
- Audit support
- Records management
Additionally:
- Maintain documents and records in the relevant electronic management system, ensuring content is prioritized and kept up to date.
- Ensure compliance with global and local documentation and records management requirements.
- Establish new and modify existing documentation to ensure accuracy and prevent errors or product issues.
- Manage document workflows from initiation to approval.
- Monitor and manage assigned workflows daily.
- Review incoming documents for completeness and compliance with GDP; support initial review for end-users.
- Work with technical teams to keep technical documentation current.
- Assist in generating reports on document workflows.
- Coordinate with cross-functional departments to review documents and assign metadata when adding documents to the electronic system.
- Manage retention of GMP-related records according to document type and record class code.
Other responsibilities include:
- Providing admin support, such as monitoring review comment backlogs and organizing large review meetings.
- Training personnel on document control interfaces.
- Supporting site self-inspections related to document control and the electronic management system.
*** The above list is not exhaustive. ***
Experience and Requirements:
- 3 to 4 years of experience as a Document Controller, preferably with quality experience in the Pharma/Biotech industry.
- Relevant tertiary qualification in business or science.
- Ability to create prototype implementations to test documentation accuracy and effectiveness is a plus but not essential.
IT Systems:
- EDMS experience is essential.
- Advanced proficiency in MS Office Suite.
*** 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 csynnott@kenny-whelan.ie.
#J-18808-Ljbffr