QA – Validation Specialist
📍 Sligo | Permanent | Biotechnology
Are you a QA professional with validation experience in a GMP environment?
Looking to grow your career at a biotech site that's expanding and gaining a strong reputation?
This is an opportunity to join a high-performing QA team supporting facility, equipment, and utility qualification for a site going from strength to strength.
You’ll be working on diverse and complex validation projects, with exposure to new product introductions, cross-functional teams, and a strong emphasis on quality risk management.
🔍 What you'll do:
- Act as QA point of contact for validation and compliance issues across the site.
- Review and approve validation protocols and reports for equipment, facilities, and utilities.
- Support QA oversight for technology transfers and manufacturing start-up activities.
- Lead and manage QMS elements: deviations, change controls, CAPAs, audits, vendor management.
- Ensure timely review of SOPs, batch records, validation documents, and risk assessments.
- Represent QA on project teams across Operations, QC, Engineering, and more.
- Drive continuous improvement in QA systems and site processes.
✅ What you'll need:
- 3+ years in Quality Assurance with validation experience in a GMP-regulated setting.
- Strong working knowledge of QMS systems, risk tools (e.g. FMEA), and regulatory standards.
- Excellent communication and cross-functional collaboration skills.
- A background in Science, Engineering, or a related discipline.
⭐ Why join?
- Site is in growth mode with exciting projects and product launches underway.
- Leadership team is inclusive, and current staff rate the culture and role variety highly.
- You'll be part of a tight-knit QA team with a real voice in site quality decisions.
Interested in learning more?
Send your CV or message me directly to set up a confidential chat.
