Quality Systems Specialist – QA & Validation

PE Global (UK); Tipperary; Hybrid; EUR 52,000 - 76,000; Full time

Job summary

PE Global (UK) is seeking a Quality Specialist – Quality Systems for a client site in Tipperary on an 11-month hybrid contract. The role supports day-to-day QA activities within the Quality Systems Centre of Excellence, ensuring cGMP compliance and driving continual improvements across the Ballydine site.

The successful candidate will manage quality agreement activities, supplier qualification support, root-cause investigations for deviations and CAPAs, and QA oversight of analytical/microbial

Qualifications

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.
• 3+ years of Quality Assurance, Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated GxP pharmaceutical or biopharmaceutical environment.
• Experience reviewing analytical/microbiological investigations, laboratory change controls, stability protocols, environmental monitoring data, or sterility parameters.
• Knowledge of method validation, verification, and transfer principles per ICH guidelines.
• Practical knowledge of environmental monitoring and microbiological testing methodologies.
• Exposure to equipment qualification and validation packages, e.g., Kneat/ProCal.
• Understanding of Quality Agreements, Change Agreements, and SAP Master Data governance.

Responsibilities

• Oversee Quality Systems, Investigations & CAPA activities and perform deviation trending.
• Lead CAPA lifecycle and ensure effective corrective and preventive actions.
• Coordinate, track, and support investigations of quality issues and customer complaints with cross-functional teams.
• Prepare annual reviews to verify validation status and regulatory compliance.
• Provide QA oversight for site analytical and microbiological laboratories and review laboratory change controls.
• Assess and approve method validation/transfer protocols and reports for compliance.
• Support environmental monitoring programs and materials expiry evaluations.
• Maintain SAP master data governance and material status controls.

Skills

Quality Assurance

Quality Systems

CAPA Management

Deviation Investigations

Laboratory QC

Environmental Monitoring

Education

Bachelor's degree in Chemistry, Microbiology, Biology, or related field

Tools

Kneat

ProCal

SAP

Job description

PE Global (UK) is seeking a Quality Specialist – Quality Systems for a client site in Tipperary on an 11-month hybrid contract. The role supports day-to-day QA activities within the Quality Systems Centre of Excellence, ensuring cGMP compliance and driving continual improvements across the Ballydine site.

The successful candidate will manage quality agreement activities, supplier qualification support, root-cause investigations for deviations and CAPAs, and QA oversight of analytical/microbial