SIGNUP

Job Opportunities

Find jobs near you, whether onsite, hybrid, or remote.
  • Similar Jobs to: Helpdesk Service Controller
IrishJobs
Document ControllerIrishJobs • Limerick, Wexford, Ireland
Apply Now
IrishJobs

Document Controller

IrishJobs
  • IE
    Limerick, Wexford, Ireland
  • IE
    Limerick, Wexford, Ireland
Apply Now

About

Job Title:Document Controller About:A cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking highly motivated, organised and detail-oriented Document Controller to support our new Biologics Manufacturing Facility. The ideal candidate is a highly organised and a methodical professional who fosters a positive team environment. Main Purpose and Objectives of the Position: As a Document Controller, you will be responsible for electronic documentation and records management oversight at the new Limerick site. This role is responsible for execution, maintenance, and administration of document management systems. 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. TheDocument Controller will aid in start-up and routine operation of the document and records management program execution in particular: Document management including metadata Revision and Change control Quality Systems support Audit support Records Management Key Responsibilities: Maintain Doc Controller role for all 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 . Assist administration and generation of regular reporting of document workflows Meet with cross functional departments to review documents and assign meta data when adding documents into Electronic Management System Manage Retention of GMP Related Records in accordance with Document Type and Record Class Code. Manage and facilitate 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 functions to ensure their document needs are captured as required. General admin 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 through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or internal auditing and compliance groups. Support Site Self Inspections associated with Document Control & the Electronic Management System. This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises. Basic Qualifications: Required; High school diploma, or equivalent. Preferable; You will have a relevant third level business / science qualification with at least 3 year's work experience ideally from a regulated industry. Additional Information: Ability to work onsite, 8-hour days Monday through Friday; Additional hours may be required to support the project, inspections or audit as necessary Preferred but not required: Ability to create prototype implementations to test documentation accuracy and effectiveness Experience working in Document control in a GMP environment. Skills: Document Controller Compliance GDP

TLNT1_IJ

  • Limerick, Wexford, Ireland

Languages

  • English
Notice for Users

This job comes from a TieTalent partner platform. Click "Apply Now" to submit your application directly on their site.