Sr. Spclst, Quality Systems & Compliance Auditor

Merck Sharp & Dohme Corp

Tipperary, Ireland
**
Gmp auditing experience
Health authority inspection hosting
Root cause analysis and capa management
** Merck Sharp & Dohme Corp is seeking a Senior QA Internal Auditor for their Ballydine site in Tipperary, Ireland. The role focuses on internal audit leadership, compliance with regulatory standards, and fostering a culture of continuous improvement within the quality management system. **

Job Summary

  • The role supports the internal audit program and inspection readiness activities to ensure compliance, safety, and reliable supply to customers.
  • Candidates will lead the preparation and hosting of Health Authority inspections and Divisional GMP Audits while maintaining current technical and regulatory knowledge.
  • The position requires evaluating root cause analyses, monitoring CAPA completion, and verifying effectiveness for complete remediation of audit findings.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Senior QA Internal Auditor for their Ballydine site in Tipperary, Ireland. The role focuses on internal audit leadership, compliance with regulatory standards, and fostering a culture of continuous improvement within the quality management system. **

Skills & Requirements

Must-have

  • GMP auditing experience
  • Health Authority inspection hosting
  • Root cause analysis and CAPA management
  • US and European cGMP guidelines knowledge
  • Internal audit program leadership

Nice-to-have

  • Lean principles application
  • Continuous improvement methodologies
  • Global team collaboration skills
  • Advanced problem-solving abilities
  • Training delivery on GMP issues

Key Requirements

  • Degree in Science, Pharmacy, or related discipline
  • Pharmaceutical industry experience in GMP environment
  • Extensive knowledge of ICH and international regulatory requirements

Work Rights

Not specified

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