GMP Quality Engineer: Investigations & Change Control

Eurofins; Ringaskiddy; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Pension

Private Medical Insurance

Life Assurance

Annual bonus

Birthday Holiday

Zusammenfassung

Eurofins in Ringaskiddy, Co. Cork, Ireland, seeks a Quality Specialist Engineer to support GMP operations. The role focuses on investigations, change controls, and compliance, ensuring regulatory standards and continuous improvement within maintenance and engineering functions.

You'll provide guidance on investigations, document reviews, and CAPA implementations, while coaching colleagues on GMP practices and collaborating across functions to uphold audit readiness and safety standards.

Qualifikationen

• Strong GMP understanding and quality systems in regulated environments.
• Experience guiding investigations, deviations, and CAPAs.
• Ability to review GMP-critical documents and change controls.

Aufgaben

• Provide expert guidance on engineering investigations, change controls, deviations, and failure investigations in GMP contexts.
• Review, assess and approve engineering documentation including change controls, investigation reports, SOPs and GMP records.
• Identify and elevate quality or compliance issues; support timely CAPA implementations.
• Ensure engineering activities meet GMP, site procedures and safety policies; maintain audit readiness.
• Coach and train engineering personnel on GMP compliance and change control best practices.
• Collaborate with cross-functional teams to drive continuous improvement and regulatory alignment.

Kenntnisse

GMP knowledge

Investigations oversight

Change controls

Documentation review

Quality systems

Ausbildung

BSc in Biotechnology, Chemistry, Engineering, or related

Jobbeschreibung

Eurofins in Ringaskiddy, Co. Cork, Ireland, seeks a Quality Specialist Engineer to support GMP operations. The role focuses on investigations, change controls, and compliance, ensuring regulatory standards and continuous improvement within maintenance and engineering functions.

You'll provide guidance on investigations, document reviews, and CAPA implementations, while coaching colleagues on GMP practices and collaborating across functions to uphold audit readiness and safety standards.