Documentation Controller: Compliance & Audit Readiness Lead

AbbVie Inc.; Sligo; On-site; EUR 35,000 - 52,000; Full time

Job summary

AbbVie Inc. is seeking a highly organised Documentation Controller to manage site documentation systems, ensuring quality, regulatory, and operational compliance.

You will control, distribute, maintain, and archive critical documents while supporting continuous improvement and inspection readiness. Responsibilities include handling global documentation system outputs, issuing controlled documents, auditing documents, and supporting regulatory inspections.

Qualifications

• Qualification in Business Administration, Office Administration, or a related discipline.
• Strong IT proficiency, including document management systems and Microsoft Office applications.
• Excellent organisational skills with strong attention to detail.
• Strong written and verbal communication skills.

Responsibilities

• Receive and manage documents from the Global Documentation Management System.
• Generate, update, maintain, and issue internal controlled documentation.
• Manage and control changes to documented procedures.
• Conduct documentation audits and ensure current approved document revisions are available across the site.
• Issue and manage batch record documentation.
• Control the storage and archiving of completed batch records.
• Maintain validation and engineering/process validation documentation.
• Process and manage document change requests.
• Support and comply with all EHS&E standards, procedures, and policies.
• Provide support and administration for the Document Centre Helpdesk.
• Support regulatory inspection and PAI readiness activities.
• Compile, analyse, and report departmental metrics and KPI data.
• Collaborate with cross-functional teams to ensure document control processes meet compliance requirements.
• Drive continuous improvement initiatives related to documentation management.

Skills

IT proficiency

Organisational skills

Written & verbal communication

Education

Business Admin / Office Admin degree

Tools

Document management systems

Microsoft Office

Job description

AbbVie Inc. is seeking a highly organised Documentation Controller to manage site documentation systems, ensuring quality, regulatory, and operational compliance.

You will control, distribute, maintain, and archive critical documents while supporting continuous improvement and inspection readiness. Responsibilities include handling global documentation system outputs, issuing controlled documents, auditing documents, and supporting regulatory inspections.