Senior Project Document Controller
Kenny-Whelan are hiring a Senior Project Document Controller for one of its Global Life Science Companies in Limerick.
Contact: Carmel Synnott : csynnott@kenny-whelan.ie or call on 087 7422268
Profile of the Role:
Responsible for Electronic Documentation and Records Management and also responsible for Execution, Maintenance, and Administration of Document Management Systems.
Description of Duties:
1. The Senior Document Controller will aid in start-up and routine operation of the document and records management program execution in particular:
- Document management
- Revision and Change control
- Audit support
- Records Management
- Maintain documents and records in the relevant Electronic Management System, ensure that the right content is prioritized and that content is kept up to date over time.
- Ensure compliance to Global and Local Documentation and Records Management requirements.
- Establish new and modify existing documentation in a manner which will achieve accuracy and avoid errors and 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 they are complete and aligned with GDP, supporting initial review of documentation for end-users.
- Ensure that technical documentation is kept up to date with the support of technical team members for the creation of content.
- Meet with cross-functional departments to review documents when adding documents into the Electronic Management System.
- Manage Retention of GMP Related Records in accordance with Document Type and Record Class Code.
- Support Site Self Inspections associated with Document Control & the Electronic Management System.
*** The above is not an exhaustive list of duties ***
Experience and Requirements:
- 5 years + experience as Document Controller supporting senior management with preferred experience in the Pharma/Biotech industry essential.
- Relevant 3rd level business / science qualification or other.
- Strong interpersonal skills and the ability to adapt 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.
Kenny-Whelan Contact:
For further information please contact Carmel Synnott on 087 7422268 or send your updated CV to csynnott@kenny-whelan.ie
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