Quality Systems & Compliance Specialist

PE Global; Tipperary; On-site; EUR 65,000 - 90,000; Full time

Job summary

PE Global is seeking a Contract Associate Quality Specialist to support day-to-day QA activities at the Ballydine facility in Tipperary. You will oversee deviation investigations, CAPA, and customer complaints while ensuring cGMP compliance and robust quality systems.

The role covers analytical/microbiological lab oversight, method validation, environmental monitoring, and supplier qualification support within a fast-paced CoE team.

Qualifications

• 3+ years in Quality Assurance, Quality Systems, or Lab QC in regulated pharma.
• Experience reviewing analytical/microbiological investigations and change controls.
• Knowledge of ICH/Q2 and regulatory filings.

Responsibilities

• Oversee deviation investigations, CAPA definition and execution.
• Coordinate customer complaint investigations with cross-functional teams.
• Manage QA oversight for analytical/microbiological labs and method validation.
• Maintain QA registers for Quality and Change Agreements; support supplier qualification.

Skills

Quality Assurance

Quality Systems

GxP

deviation investigations

CAPA

Environmental Monitoring

Analytical Method Validation

Audit & Walkdown

SAP Master Data governance

Change Agreements

Education

Degree in Chemistry/Microbiology/Science/Pharmacy/Engineering

Tools

Kneat

ProCal

SAP

Job description

PE Global is seeking a Contract Associate Quality Specialist to support day-to-day QA activities at the Ballydine facility in Tipperary. You will oversee deviation investigations, CAPA, and customer complaints while ensuring cGMP compliance and robust quality systems.

The role covers analytical/microbiological lab oversight, method validation, environmental monitoring, and supplier qualification support within a fast-paced CoE team.