Job Description
DOCUMENT CONTROLLERS are required by CareerWise Recruitment for our multinational client for their new BioTech project in Limerick. This is an initial 12-month contract opportunity, and site presence in Limerick is required on a Monday-to-Friday basis. The DOCUMENT CONTROLLER will be responsible for overseeing electronic documentation and records management at the new Limerick site.
Role of this Position
* Maintain the Doc Controller role for all documents and records stored in the relevant Electronic Management System, ensuring that the correct content is prioritized and kept up to date over time.
* E nsure compliance with Global and Local Documentation and Records Management requirements.
* Establish new and modify existing documentation in a manner that achieves accuracy and avoids errors and product recalls or issues.
* Manage the flow of documents from workflow initiation to approval.
* Perform day-to-day management and monitoring of assigned workflows.
* Review and accept incoming documents to ensure they are complete and aligned with GDP, providing initial support for end-users.
* Ensure that technical documentation is kept up to date with the assistance of technical team members for creating content.
* Assist in the administration and generation of regular reporting on document workflows.
* Meet with cross-functional departments to review documents and assign metadata when adding documents to the Electronic Management System.
* Manage the retention of GMP-related records in accordance with Document Type and Record Class Code.
* Manage and facilitate the reconciliation process for executable records.
* Monitor and ensure that periodic document reviews are performed within the Electronic Management System.
* Follow up with document owners to ensure timely review and updating.
* Collaborate with Quality, Learning and Development, and other Lilly functions to ensure their document needs are captured as required.
* Provide general administrative assistance, including monitoring review comment backlogs, organizing large document review meetings, etc.
* Provide training to appropriate personnel on doc control interfaces.
* Support external and internal audits by providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or Lilly internal auditing and compliance groups.
* Support Site Self-Inspections associated with Document Control & the Electronic Management System.
Job Requirements
* Relevant third-level business/science qualification.
* At least three years' work experience ideally from a regulated industry.
* Ability to work onsite, 8-hour days, Monday-to-Friday, with additional hours required to support the project, inspections, or audits as necessary.