Document Control Specialist

Overview

We are aiding a leading pharmaceutical facility in a significant digital transformation, particularly through the deployment of a new global Laboratory Information Management System (LIMS). This role centers on managing document control, change management, and SOP conversions to ensure precise migration of all lab documentation into a digitally controlled system, supporting the shift to a paper-free environment.

Key Responsibilities

• Oversee change control workflows within TrackWise, facilitating LIMS implementation tasks.
• Handle updates, amendments, and corrections to SOPs aligned with GMP compliance.
• Upload and maintain documents on Documentum, ensuring proper management.
• Coordinate review and approval processes among QA, QC, and project teams.
• Assist in converting paper-based procedures into organized digital formats.
• Ensure documentation meets SDLC, validation, and regulatory compliance standards.
• Maintain readiness for audits through accurate document control and version tracking.
• Support validation efforts with precise documentation of protocols, reports, and training content.

Requirements

• Between 1 to 4 years of experience in pharmaceutical or GMP-regulated settings.
• Demonstrated experience in managing change control processes, preferably with TrackWise.
• Familiarity with document management platforms, Documentum experience is advantageous.
• Solid understanding of SOP management, document lifecycle, and GxP documentation standards.
• Meticulous attention to detail with an organized and systematic work approach.
• Strong written communication skills, especially for producing technical documentation.

Preferred Qualifications

• Experience with LIMS systems or laboratory workflow environments.
• Background in supporting validation and SDLC documentation processes.
• Knowledge of QC laboratory procedures or analytical workflows.

Contract Information

• Duration: 12-month fixed contract.
• Work Location: Onsite, five days per week in the Galway area.
• Start Date: Immediate availability preferred.