GMP Compliance Engineer — Hybrid, 11-Month Contract

Life Science Recruitment

Carlow

Hybrid

EUR 45,000 - 60,000

Full time

3 days ago
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Job summary

Life Science Recruitment is seeking an Engineering Compliance Specialist for a 11-month contract in Carlow. The role focuses on ensuring compliance, safety, and reliable product supply, including reviewing GMP documentation and leading change controls.

Responsibilities include authoring and reviewing controlled documents, conducting RCA with cross-functional teams, and maintaining regulatory compliance across Irish, European, and international standards.

Qualifications

  • Diploma or higher in related discipline.
  • Experience in manufacturing GMP setting is preferred.
  • Effective communication and interpersonal skills.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report and policy writing skills.
  • Lean Six Sigma methodology experience.

Responsibilities

  • Direct and lead deviations, out of tolerance conditions and unexpected results; conduct root cause analysis and implement corrective actions.
  • Support Engineering documentation review (electronic logs).
  • Support Audit Readiness activities.
  • Support Internal Audit programs.
  • Collaborate with Engineering and other departments to maintain compliance posture.
  • Ensure compliance with cGMP and global policies; promote a safe, compliant culture in Carlow.

Skills

Root Cause Analysis
Regulatory knowledge
Communication skills
GMP knowledge

Education

Diploma or higher in related discipline

Job description

Life Science Recruitment is seeking an Engineering Compliance Specialist for a 11-month contract in Carlow. The role focuses on ensuring compliance, safety, and reliable product supply, including reviewing GMP documentation and leading change controls.

Responsibilities include authoring and reviewing controlled documents, conducting RCA with cross-functional teams, and maintaining regulatory compliance across Irish, European, and international standards.

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