Manufacturing Batch Records Lead

Manufacturing Batch Records Lead Place of work: Białystok 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 checklists Coordinating verification activities at multiple locations and stages of deployments Collaboration with project teams to ensure compliance with regulatory requirements and internal procedures Verification of batch records for completeness, accuracy, and compliance with GMP/GxP regulations Conducting audits and inspections to ensure compliance with quality and regulatory requirements Providing training and guidance to team members on MBR verification processes and procedures Identifying and reporting non-conformities and deviations from established procedures and standards Developing and implementing corrective actions to address non-conformities and deviations Ensuring that all activities are performed in accordance with established procedures, policies, and regulations