Manufacturing Batch Records Lead

Manufacturing Batch Records Lead Place of work: Warsaw Your scope of responsibilities Verification of global and local MBR regarding completeness, correctness, and compliance with GMP/GxP Ensuring consistency of MBR with MES architecture, global templates, and PAS-X standards Checking integration points of MBR with ERP, WMS, LIMS, and OT systems Maintaining global verification standards as well as protocols and checklist Coordinating verification actions on multiple locations and stages of implementations Collaboration with project teams to ensure compliance with regulatory requirements and internal procedures Verification of documentation and records in accordance with GMP/GxP regulations Conducting audits and inspections to ensure compliance with quality and regulatory requirements Providing guidance and support to manufacturing sites to ensure compliance with MBR and regulatory requirements Developing and implementing procedures for the verification of MBR Maintaining accurate and up-to-date records of MBR and related documents