Manager Electronic Batch Record (EBR)
About this role
Tolmar: Manager Electronic Batch Record (EBR)
Description
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Purpose and Scope
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The Manager, Electronic Batch Records (EBR), provides people, business, and technical leadership for Tolmar’s EBR platform and team. This role establishes priorities, develops staff, allocates resources, and oversees system administration, configuration, validation, lifecycle management, and continuous improvement in support of GMP manufacturing. The manager partners with Manufacturing, MS&T, Quality, Validation, IT, Engineering, Supply Chain, and Regulatory Affairs to ensure EBR workflows, master batch records, electronic forms, user access, electronic signatures, audit trails, and system changes support compliant batch execution, data integrity, FDA 21 CFR Part 11 requirements, inspection readiness, and Tolmar’s digital manufacturing strategy.
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Essential Duties & Responsibilities
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