- Issue production batch records, worksheets, packaging records, and related controlled documents using approved systems and current effective versions.
- Assign and verify batch numbers, process order numbers, and document revisions prior to issuance.
- Ensure only current, approved documentation is issued for manufacturing use.
- Print, prepare, stamp, and control manufacturing documentation according to site procedures.
- Maintain document accountability, issuance logs, and controlled records.
- Support Manufacturing, Planning, Quality Assurance, and Process Sciences by preparing records for scheduled production activities.
- Process requests for additional pages, replacement documentation, and document revisions while maintaining traceability.
- Verify issued documentation is complete, legible, accurate, and attributable to the correct batch.
- Maintain compliance with GMP, GDP, Data Integrity, and document control requirements.
- Support investigations, audits, inspections, and document retrieval requests as required. (The procedures establish controlled-document accountability and retention activities.)
Typical Systems Used
- SAP
- Electronic Document Management Systems (eDMS/Vault)
- POMSnet / MES (where applicable)
- Batch record tracking and issuance tools
- Knowledge of GMP documentation practices.
- Strong attention to detail and accuracy.
- Experience with document control and records management.
- Ability to work with Manufacturing, QA, Planning, and Supply Chain teams.
- Proficiency with SAP and document management systems.
- Strong organizational and compliance mindset.
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