GMP Validation & Lab Analytics Specialist

QCS Staffing Ltd; Carlow; Sur place; EUR 41 000 - 76 000; Plein temps

Résumé du poste

QCS Staffing Ltd in Carlow, Ireland, is seeking a Laboratory Analytical Specialist for an initial 11-month contract. The role focuses on qualification/validation documentation, cycle development, and ensuring cGMP compliance within a GMP-regulated environment.

You will support audits, perform root cause analysis, and collaborate with Production, Maintenance, and Quality teams. The ideal candidate has strong experience in equipment validation, CTU qualification, sterile fill-finish

Qualifications

• Experience in equipment and process validation within GMP-regulated environments.
• Ability to analyse complex technical data and link findings to performance.
• Strong communication and collaboration with cross-functional teams.

Responsabilités

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

Connaissances

GMP compliance

Root cause analysis

Technical project leadership

Technical report writing

Description du poste

QCS Staffing Ltd in Carlow, Ireland, is seeking a Laboratory Analytical Specialist for an initial 11-month contract. The role focuses on qualification/validation documentation, cycle development, and ensuring cGMP compliance within a GMP-regulated environment.

You will support audits, perform root cause analysis, and collaborate with Production, Maintenance, and Quality teams. The ideal candidate has strong experience in equipment validation, CTU qualification, sterile fill-finish