QCS Staffing Ltd

Laboratory Analytical Specialist - Carlow, Ireland - Initial 11-Month Contract - Life Sciences Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting-edge drugs. As they continue to grow, they’re seeking an experienced Laboratory Analytical Specialist to support their dynamic team and drive forward groundbreaking projects in Carlow.

What you’ll deliver:

• Design, review, approve, and execute qualification/validation documentation and cycle development studies, ensuring they meet GMP and regulatory standards.
• Troubleshoot and resolve technical issues during studies, performing root cause analysis to address equipment or system failures.
• Work closely with Production, Maintenance, and Quality teams and act as the validation representative for projects and global technical forums.
• Ensure full cGMP compliance, support audits and inspections, complete documentation and risk assessments, and close out corrective actions.

What you’ll need:

• Experience in equipment and process validation, deviation/exception management, change control, and working within GMP-regulated environments.
• Knowledge of CTU qualification, thermal mapping, sterilisation (VHP, autoclave, SIP, dry heat), isolators, and sterile fill-finish equipment.
• Ability to analyse complex technical data, perform root cause analysis, and link findings to equipment or process performance.
• Strong communication, ability to lead technical projects, and high-quality report/policy writing, collaborating with Quality, Maintenance, Production, and global teams.