GMP Quality Analytics & Process Lead

GE HealthCare; Cork; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading healthcare company in Cork is seeking a Quality Excellence & Process Analytics Lead. The role involves managing GMP documentation systems, ensuring compliance with regulations, and supporting quality investigations. The ideal candidate has a degree in a scientific field and solid experience in a GMP environment. This position offers competitive compensation and the opportunity for career growth in a collaborative culture.

Qualifications

• Solid experience in a GMP-regulated environment, with exposure to QA, QC, and validation.
• Strong understanding of CPV principles, quality documentation systems, and laboratory data lifecycle.
• Experience coordinating CAPAs, change controls, and investigations in a regulated environment.

Responsibilities

• Lead and maintain controlled documentation systems including SOPs and validation protocols.
• Oversee management and compliance of quality records within the QC department.
• Analyze QC data to support CPV activities and identify trends.

Skills

GMP regulations

Quality Assurance (QA)

Quality Control (QC)

Data analysis tools (Excel, Minitab)

Cross-functional collaboration

Education

Bachelor’s or master’s degree in a scientific or engineering discipline

Tools

Trackwise

Veeva

LIMS

Job description

A leading healthcare company in Cork is seeking a Quality Excellence & Process Analytics Lead. The role involves managing GMP documentation systems, ensuring compliance with regulations, and supporting quality investigations. The ideal candidate has a degree in a scientific field and solid experience in a GMP environment. This position offers competitive compensation and the opportunity for career growth in a collaborative culture.