Document Controller

Morgan McKinley; Dublin; On-site; EUR 55,000 - 70,000; Full time

Job summary

Morgan McKinley is seeking a Senior Document Controller to join a leading pharmaceutical organisation in Ireland. The role focuses on GMP record management, archiving, and retrieval, ensuring compliance with GDP and retention schedules.

You will work with Quality, Operations and internal teams to support audits, inspections and process improvements in document management across the site.

Qualifications

• Previous experience in document control, records management, archiving or a related pharmaceutical/GMP environment.
• Strong understanding of Good Documentation Practices (GDP) and controlled documentation.
• Experience working with electronic document or records management systems.

Responsibilities

• Manage the archival of GMP records in line with established record retention schedules and regulatory requirements.
• Coordinate the retrieval of records from internal and external storage providers as required.
• Provide archive support during audits and inspections, ensuring records can be retrieved quickly and accurately.
• Manage the destruction of records at the end of their approved retention period.
• Resolve queries and requests relating to electronic record management systems.
• Provide guidance and training to staff on electronic record management processes and systems.

Skills

Document control

GDP awareness

Regulatory inspections

Audits

Archiving

Stakeholder coordination

Tools

EDMS

Job description

Location: Dublin, Dun Laoghaire, 5 days onsite

Contract: 12 months, with potential for extension

About the Role

We are seeking an experienced Senior Document Controller to join a leading pharmaceutical organisation in Ireland. This role will support the effective management, archiving and retrieval of GMP records, ensuring compliance with record retention requirements and Good Documentation Practices.

The successful candidate will work closely with Quality, Operations and other internal teams, providing archive support during audits and inspections and helping to drive improvements across document and records management processes.

Key Responsibilities

• Manage the archival of GMP records in line with established record retention schedules and regulatory requirements.
• Coordinate the retrieval of records from internal and external storage providers as required.
• Provide archive support during audits and inspections, ensuring records can be retrieved quickly and accurately.
• Manage the destruction of records at the end of their approved retention period.
• Resolve queries and requests relating to electronic record management systems.
• Provide guidance and training to staff on electronic record management processes and systems.
• Issue, review, reconcile and archive paper logbooks in accordance with Good Documentation Practices.
• Prepare records for offsite storage and coordinate the transportation of documents to external storage facilities.
• Maintain accurate electronic tables of contents for QA procedures and methods.
• Provide site-wide support with the reconciliation of controlled forms.
• Prepare document listings and supporting documentation for audits and inspections.
• Gather and analyse archive metrics to identify opportunities for improved efficiency.
• Identify and implement improvements to archival, retrieval and document management procedures.
• Work with departments across the site to ensure records are archived consistently and according to agreed schedules.
• Communicate archive deliverables, progress and relevant metrics clearly to management and stakeholders.
• Support the Quality Systems team with metrics, audits, inspections and other deliverables as required.
• Undertake additional duties and projects as assigned by management.

Key Skills & Experience

• Previous experience in document control, records management, archiving or a related pharmaceutical/GMP environment.
• Strong understanding of Good Documentation Practices (GDP) and controlled documentation.
• Experience working with electronic document or records management systems.
• Strong attention to detail and accuracy when handling controlled records.
• Experience supporting audits and regulatory inspections.
• Strong organisational and coordination skills.
• Ability to manage confidential and compliance-critical documentation.
• Comfortable working with multiple stakeholders across a site environment.
• Strong analytical skills, with the ability to gather and interpret process metrics.
• Ability to identify process improvements and drive greater efficiency.
• Excellent written and verbal communication skills.