GMP Documentation & Compliance Specialist

AbbVie Inc.; Ireland; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie Inc. in Ireland seeks a detail-oriented documentation control professional to issue and manage manufacturing records and controlled documents. You will verify batch numbers, ensure current forms are used, and maintain traceability across QA, Planning and Supply Chain teams.

Proficiency with SAP and eDMS systems is required, along with strong organizational skills and a compliance mindset to uphold GMP standards in a fast-paced manufacturing environment.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP documentation

SAP

Documentation control

Attention to detail

Cross-functional collaboration

Tools

eDMS/Vault

POMSnet / MES

Job description

AbbVie Inc. in Ireland seeks a detail-oriented documentation control professional to issue and manage manufacturing records and controlled documents. You will verify batch numbers, ensure current forms are used, and maintain traceability across QA, Planning and Supply Chain teams.

Proficiency with SAP and eDMS systems is required, along with strong organizational skills and a compliance mindset to uphold GMP standards in a fast-paced manufacturing environment.