Job Description
DOCUMENT CONTROLLERS are required by CareerWise Recruitment for a multinational client's new BioTech project in Limerick. The initial 12-month contract is on offer, and site presence in Limerick is required from Monday to Friday.
The DOCUMENT CONTROLLER will be responsible for electronic documentation and records management oversight at the new Limerick site. This role involves the execution, maintenance, and administration of document management systems.
Role of this Position
* Maintain the Doc Controller role for all documents and records maintained in the relevant Electronic Management System, ensuring that the right content is prioritized and kept up to date over time.
* Ensure 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 initiation of workflow 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, supporting the 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 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 document periodic reviews are performed within the Electronic Management System.
* Follow up with document owners to ensure review and updating on a timely basis.
* Work closely with Quality, Learning and Development, and other Lilly functions to ensure their document needs are captured as required.
* Provide general administrative assistance: monitor review comment backlogs, organize and facilitate 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
* A relevant third-level business/science qualification.
* At least 3 years' work experience ideally from a regulated industry.
* Able to work onsite, 8-hour days, Monday to Friday, with additional hours may be required to support the project, inspections, or audit as necessary.