Document Controller

CareerWise Recruitment; Cork; On-site; EUR 40,000 - 55,000; Full time

Job summary

A recruitment agency is seeking a Document Controller for a Biotech client based in Limerick. The role involves electronic documentation oversight, ensuring compliance with documentation standards, and managing document workflows. The ideal candidate should have at least 3 years of experience in a regulated industry, possess a relevant qualification, and be able to work onsite during standard business hours.

Qualifications

• High school diploma or equivalent required.
• At least 3 years of work experience from a regulated industry.
• Ability to work onsite, 8-hour days, Monday to Friday.

Responsibilities

• Maintain Doc Controller role for all documents and records.
• Ensure compliance with documentation requirements.
• Manage document workflows from initiation to approval.

Skills

Document management systems

Compliance with documentation requirements

Audit support

Attention to detail

Education

Relevant third level business/science qualification

Job description

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Document Controller required for Biotech client based in Limerick. Contract role.

As a Document Controller, you will be responsible for electronic documentation and records management oversight at Limerick site. This role is responsible for execution, maintenance, and administration of document management systems.

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.

Requirements:

• 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.
• Ability to work onsite, 8-hour days – Monday through Friday;
• Additional hours may be required to support the project, inspections or audit as necessary
• Ability to create prototype implementations to test documentation accuracy and effectiveness
• Experience working in Document control in a GMP environment.