Manufacturing Batch Records Lead

Manufacturing Batch Records Lead Place of work: Gdańsk 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 Coordination of verification activities at multiple locations and stages of deployments Collaboration with project teams and stakeholders to ensure compliance with regulatory requirements and internal policies Verification of batch records against quality control procedures and documentation Control of batch record data integrity and accuracy Identification of non-conformities and implementation of corrective actions Continuous improvement of the batch record management process through training, audits, and process optimization