Document Controller (Contract

CareerWise Recruitment; Limerick; Sur place; EUR 38 000 - 47 000; Plein temps

Résumé du poste

CareerWise Recruitment is seeking a Document Controller for a Life Sciences client in Limerick on a 12-month contract. The successful candidate will be highly organised and methodical, fostering a positive team environment.

Responsibilities include maintaining the document control system, ensuring compliance with GDP and regulatory requirements, and managing the flow of documents from initiation through approval. Strong attention to detail and cross-functional collaboration are essential.

Qualifications

• Requires high school diploma and relevant third level business/science qualification.
• At least 3 years’ work experience ideally from a regulated industry.

Responsabilités

• Maintain Doc Controller role for documents and records in the EDMS, ensure content is up to date.
• Ensure compliance with Global and Local Documentation and Records Management requirements.
• Establish and modify documentation to ensure accuracy and avoid errors.
• Manage the flow of documents from initiation to approval.
• Monitor day-to-day document workflows and check incoming documents for completeness.
• Support alignment to GDP and assist end-users with documentation reviews.
• Update technical documentation with input from the technical team.

Connaissances

Organisational skills

Documentation control

Attention to detail

Cross-functional collaboration

Formation

High school diploma

Science/business degree preferred

Outils

EDMS (Electronic Document Management System)

MS Office

Description du poste

Document Controller required for Life Sciences client based in Limerick. Initial 12 month contract.

The ideal candidate is a highly organised and a methodical professional who fosters a positive team environment.

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.