ERP Transformation Quality Assurance Specialist

7 days ago


Galway, Galway, Ireland beBeeCompliance Full time €60,000 - €90,000
Job Description

This role involves leading the quality and compliance aspects of a SAP Cloud ERP transformation. The successful candidate will ensure GxP compliance, data integrity, and operational excellence across regulated pharmaceutical operations.

Responsibilities:
  • Define and implement the QA strategy for SAP ERP in line with regulatory and operational requirements.
  • Establish and enforce quality governance frameworks, policies, and procedures.
  • Lead the QA workstream within the SAP S/4HANA Cloud ERP programme.
  • Collaborate with stakeholders to embed quality requirements into system design and configuration.
  • Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.
  • Support CSV activities and audit readiness.
  • Review and approve project documentation.
  • Implement measures to guarantee inspection readiness and data integrity.
  • Act as a liaison between stakeholders and teams on quality-related matters.
  • Facilitate training sessions to strengthen compliance culture.
  • Monitor quality KPIs and drive continuous improvement initiatives.
Required Skills and Qualifications
  • In-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.
  • Practical experience with Quality Management (QM) module, batch management, and traceability.
  • Familiarity with SAP Best Practices and Fit-to-Standard methodology.
  • Strong understanding of GDP, GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA++.
  • Experience supporting CSV activities and audit readiness.
  • Proven leadership of QA workstreams in large-scale ERP implementations.


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