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QM Lead Consultant

vor 1 Tag

Bad Homburg, Deutschland Avance Consulting Vollzeit

Responsibilities:- Lead the design, configuration, and deployment of SAP QM solutions for Life Sciences projects.- Collaborate with cross-functional teams (PP, MM, WM, PM) to ensure seamless integration of QM processes.- Define and implement quality inspection plans, certificates, batch management, and audit processes.- Ensure compliance with FDA, EMA, and other regulatory requirements (GxP, GMP).- Conduct workshops with business stakeholders to gather requirements and translate them into SAP solutions.- Manage testing cycles (Unit, Integration, UAT) and validation documentation per Life Sciences standards.- Provide guidance and mentorship to junior consultants and client teams.- Support data migration, cutover, and hypercare activities.- Must be fluent in communication & good in presentation.Mandatory Skills:- SAP Quality Management- Must have expertise in configuring basic QM processes. In-depth knowledge of quality planning, inspections, notifications, master data. (Batch management, Physical Sample Drawing, Stability Study, Quality Notifications, Dynamic modification functionality etc.)- Pharmaceutical industry experience and implementation experience is required.