Manufacturing Batch Records Lead

Manufacturing Batch Records Lead Place of work: Bydgoszcz 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 and protocols and checklist Coordination of verification activities at multiple locations and stages of implementation Collaboration with project teams and stakeholders to ensure compliance with regulatory requirements and internal policies Verification of batch records for completeness, accuracy, and compliance with GMP/GxP regulations Identification and resolution of discrepancies and errors in batch records Development and maintenance of procedures and guidelines for batch record management Providing training and support to production staff on batch record management and compliance with GMP/GxP regulations