GMP Documentation & Records Specialist

AbbVie; Ulster; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

AbbVie seeks a document control specialist to manage GMP documentation, batch records, and controlled documents for manufacturing operations. You will ensure accuracy, traceability, and alignment with QA, Planning, and Supply Chain teams.

Role requires proficiency with SAP and eDMS as you maintain current documentation, manage revisions, and support audits and investigations. ABBVIE offers opportunity within a global biopharma environment.

Formación

• Experience with 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.

Conocimientos

GMP documentation practices

Attention to detail

Document control

Records management

SAP

eDMS

Cross-functional collaboration

Compliance mindset

Herramientas

SAP

eDMS/Vault

POMSnet / MES

Batch record systems

Descripción del empleo

AbbVie seeks a document control specialist to manage GMP documentation, batch records, and controlled documents for manufacturing operations. You will ensure accuracy, traceability, and alignment with QA, Planning, and Supply Chain teams.

Role requires proficiency with SAP and eDMS as you maintain current documentation, manage revisions, and support audits and investigations. ABBVIE offers opportunity within a global biopharma environment.