Quality Assurance Lead
2 weeks ago
OverviewTeam Horizon is seeking a Quality Lead who will oversee the quality and compliance aspects of a SAP Cloud ERP transformation.This is a critical position to ensure GxP compliance, data integrity, and operational excellence across developing and growing pharmaceutical operations.Why you should applyWork with an Industry Leader with Global Reach, exporting to over 90 countries and holding thousands of product licenses in both human and animal health.Career Growth & Development, benefit from strong investment in employee training and professional development, with opportunities to grow within a rapidly expanding and internationally recognized business.Modern Facilities & Regulatory Excellence, Gain experience in FDA-approved, high-standard manufacturing and R&D environments, supporting innovation and quality in pharmaceutical production.What you will be doingDefining and implementing the QA strategy for SAP ERP aligned with regulatory and operational requirements.Establishing and enforcing quality governance frameworks, policies, and procedures across all relevant domains.Leading the QA workstream within the SAP S/4HANA Cloud ERP programme, aligned to an "Adopt not Adapt" methodology.Collaborating with SAP consultants, business stakeholders, and technical teams to ensure quality requirements are embedded in system design and configuration.Ensuring the ERP system complies with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.Supporting and working with the Computer System Validation (CSV) lead and supporting vendors regarding related processes and activities.Ensuring documents are reviewed and approved appropriately.Implementing audit trails, electronic signatures, and access controls to support inspection readiness and data integrity.Acting as the primary liaison across key stakeholders and the project team for all quality-related matters.Facilitating workshops and training sessions to promote quality awareness and compliance culture.Monitoring and reporting on quality KPIs and driving continuous improvement initiatives.Supporting manufacturing, supply chain, and regulatory teams with quality insights to optimise operations.What you need to applyOver five years of Quality Assurance experience in regulated pharmaceutical and CDMO settings, ensuring compliance and operational excellence.Extensive experience in ERP implementations, with a strong focus on SAP systems, and familiarity with tools such as SAP Signavio for process modelling and validation traceability.Demonstrated leadership in CSV activities and QA-related ERP projects.Experience with AI/ML tools for quality monitoring and validation (desirable).#J-*****-Ljbffr
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▷ [High Salary] Quality Assurance Lead
4 weeks ago
Roscommon, Ireland Team Horizon Full timeOverview Team Horizon is seeking a Quality Lead who will oversee the quality and compliance aspects of a SAP Cloud ERP transformation. This is a critical position to ensure GxP compliance, data integrity, and operational excellence across developing and growing pharmaceutical operations. Why you should apply - Work with an Industry Leader with Global...
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