Document Control / LIMS Change Control Analyst
Galway, County Galway, Ireland · Contracter
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- Expérience
- 1–4 yrs
- Salaire
- —
- Ouvertures
- 1
- Publié
- il y a 3 heures
- Work mode
- Au bureau
- Eligibility
- Candidates with 1 to 4 years of experience in a pharmaceutical or GMP-regulated environment, especially those with document control, change control, SOP management, or lab systems exposure, are suitable for this role.
- Resume
- Required to apply
Where you'll work
Description de l'emploi
Role overview
This contract position supports a major pharmaceutical facility in Galway, Ireland, as it rolls out a global Laboratory Information Management System (LIMS) and moves toward a largely paperless operating model. The assignment is centered on document control, change management, and the transition of SOPs into a controlled digital environment.
What you will do
- Run change control activities in TrackWise to support the LIMS rollout.
- Handle SOP updates, redlines, and controlled revisions to meet GMP expectations.
- Upload, organize, and maintain records in Documentum.
- Coordinate reviews and sign-offs across QA, QC, and project teams.
- Help convert paper-based procedures into structured digital formats.
- Make sure all documentation follows SDLC, validation, and regulatory requirements.
- Keep audit readiness high through accurate version control and document tracking.
- Support validation work by documenting protocols, reports, and training materials.
What the role requires
- 1 to 4 years of experience in a pharmaceutical or GMP-regulated setting.
- Hands-on involvement with change control processes; TrackWise experience is preferred.
- Previous use of document management platforms; Documentum experience is preferred.
- Strong background in SOP handling, document lifecycle management, and GxP documentation.
- A highly organized, detail-focused, and methodical way of working.
- Clear written communication skills, especially for technical documentation.
Nice to have
- Exposure to LIMS environments or laboratory workflows.
- Experience assisting with validation or SDLC documentation.
- Understanding of QC laboratory processes or analytical workflows.
Contract and working arrangement
This is a 12-month contract based onsite in Galway, Ireland, with five days per week onsite initially. There is flexibility after training. The role is available to start as soon as possible.
Additional information
The role supports a large-scale digital transformation within a pharmaceutical QC/laboratory environment. The work involves helping shift documentation and procedures into a controlled digital setup while maintaining compliance and audit readiness.