Document Controllers (12M+, BioTech, Limerick)

DOCUMENT CONTROLLERS required by CareerWise Recruitment for our multinational client for their new BioTech project in Limerick. Initial 12 month contract on offer and site presence in Limerick is required Monday - Friday. The DOCUMENT CONTROLLERS will be responsible for electronic documentation and records management oversight at new Limerick site. This role is responsible for execution, maintenance and administration of document management systems.

Role of this position

• 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 Lilly 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 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 3 year's work experience ideally from a regulated industry.
• Ability to work onsite, 8 hour days, Monday - Friday and additional hours may be required to support the project, inspections or audit as necessary.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.