GMP Documentation & Compliance Specialist

AbbVie Inc.; Westport; Presencial; EUR 45 000 - 75 000; Tempo integral

Resumo da oferta

AbbVie Inc. in Westport, Ireland is seeking a Document Control Specialist to manage production records and controlled documents within GMP-compliant systems.

You will assign batch numbers, verify revisions, and ensure only approved documentation is issued for manufacturing use. You will collaborate with Manufacturing, QA, Planning, and Supply Chain to prepare records for scheduled production activities and support audits and inspections.

Qualificações

• 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.

Responsabilidades

• 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.)

Conhecimentos

GMP documentation

Attention to detail

Document control

Cross-functional collaboration

SAP experience

Document management systems

Ferramentas

SAP

eDMS / Vault

POMSnet / MES

Descrição da oferta de emprego

AbbVie Inc. in Westport, Ireland is seeking a Document Control Specialist to manage production records and controlled documents within GMP-compliant systems.

You will assign batch numbers, verify revisions, and ensure only approved documentation is issued for manufacturing use. You will collaborate with Manufacturing, QA, Planning, and Supply Chain to prepare records for scheduled production activities and support audits and inspections.