Document Controller Quality On behalf of its Client, Kenny-Whelan are hiring a Document Controller Quality for one of its Global Life Sciences Companies in Limerick. Contact: Carmel Synnott: ****** 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: The Document Controller will aid in initial program start-up and routine operation of the site, as well as support site inspection readiness and execution.The Document Controller will aid in start-up and routine operation of the document and records management program execution in particular:Document management including metadataRevision and Change controlQuality Systems supportAudit supportRecords ManagementAlso:
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 completeness and alignment 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.Assist in the administration and generation of regular reporting of document workflows.Meet with cross-functional departments to review documents and assign metadata when adding documents into the Electronic Management System.Manage retention of GMP related records in accordance with Document Type and Record Class Code.General admin assistance: monitor review comment backlogs, organize and facilitate large document review meetings, etc.
Provide training to appropriate personnel on document control interfaces.Support Site Self Inspections associated with Document Control & the Electronic Management System.Experience and Requirements: 3 to 4 years' experience as Document Controller with Quality (preferred) experience in the Pharma/Biotech industry.Relevant 3rd level business/science qualification.Ability to create prototype implementations to test documentation accuracy and effectiveness preferred but not essential.IT Systems: EDMS experience essential.Ms Office Suite advanced.*** 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 send your updated CV to ******.
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