Senior QA Auditor III - Lead GxP & Compliance Audits

ThermoFisher Scientific; Athlone; On-site; EUR 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure GxP compliance across projects. You will review documents, identify root causes of non-conformances, and develop corrective actions for clients and internal teams.

Ideal candidates bring 5+ years of QA auditing experience, strong regulatory knowledge, and excellent communication for client-facing deliverables in a fast-paced environment.

Qualifications

• Bachelor's degree or equivalent and QA qualification.
• 5+ years of QA auditing experience in regulatory environments.
• Detailed knowledge of GxP and GMP guidelines.

Responsibilities

• Conduct and/or lead client, internal or GxP audits and regulatory inspections.
• Lead directed site audits, facility, vendor and subcontractor audits.
• Provide GxP consultation and support to project teams and clients.
• Lead process audits and co-audit more complex system audits
• Perform other QA audits or activities (e.g., database audits, study reports, data tables).
• Serve as resource to operational departments on audit or QA matters.
• Prepare and present audit findings at meetings.
• Provide mentorship to junior auditors.

Skills

QA auditing

GxP knowledge

Regulatory compliance

Documentation review

Risk assessment

Root cause analysis

Communication skills

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure GxP compliance across projects. You will review documents, identify root causes of non-conformances, and develop corrective actions for clients and internal teams.

Ideal candidates bring 5+ years of QA auditing experience, strong regulatory knowledge, and excellent communication for client-facing deliverables in a fast-paced environment.