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:
1. Document management
2. Revision and Change control
3. Audit support
4. Records Management
Maintain documents and records maintained 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 are complete and aligned with GDP, support 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 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:
1. 5 years + experience as Document Controller supporting senior management with preferred experience in the Pharma/Biotech industry essential
2. Relevant 3rd level business / science qualification or other
3. Strong interpersonal skills and the ability to adapt to frequent changes in priority
4. Ability to maintain accuracy.
5. Manage urgent deadlines.
IT Systems:
1. Advanced competency in Ms Office Suite, Word, Excel, PowerPoint, Outlook
2. 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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