Documentation Controller: Regulatory Docs (12‑Month, 8am–4:30pm)

ABBVIE; Sligo; On-site; EUR 42,000 - 60,000; Full time

Job summary

AbbVie seeks a highly organised Documentation Controller to manage site documentation systems, ensuring compliance with quality, regulatory, and operational requirements. You will control, distribute, maintain, and archive critical documentation while supporting improvement and inspection readiness across the site.

Key responsibilities include handling documents from the Global Documentation Management System, issuing controlled docs, managing changes, audits, batch records, validation docs, and

Qualifications

• Qualification in Business Administration, Office Administration, or a related discipline.
• Strong IT proficiency, including document management systems and Microsoft Office.
• Excellent organisational skills with strong attention to detail.
• Strong written and verbal communication skills.
• Previous experience in a document control, quality, compliance, or administrative role within a regulated environment.
• Experience managing technical or quality documentation.
• Experience working within pharmaceutical, medical device, biotechnology, or manufacturing industries.

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

Attention to detail

Organisational skills

Communication skills

Regulated environment experience

Education

Business Administration qualification

Tools

Microsoft Office

Document management systems

Job description

AbbVie seeks a highly organised Documentation Controller to manage site documentation systems, ensuring compliance with quality, regulatory, and operational requirements. You will control, distribute, maintain, and archive critical documentation while supporting improvement and inspection readiness across the site.

Key responsibilities include handling documents from the Global Documentation Management System, issuing controlled docs, managing changes, audits, batch records, validation docs, and