Senior Document Controller

Overview

We are looking for a seasoned Senior Document Controller to join a prominent pharmaceutical company based in Dublin, Dun Laoghaire. This full-time contract position spans 12 months with the possibility of extension and requires onsite presence five days a week. The role focuses on the thorough administration, archiving, and retrieval of GMP records, guaranteeing adherence to retention policies and Good Documentation Practices.

Primary Duties

• Oversee the archiving of GMP documentation following established retention timelines and regulatory mandates.
• Coordinate document retrieval from both in-house and external archival providers on demand.
• Provide critical archive support during audits and inspections to ensure swift and precise record access.
• Manage systematic destruction of records upon expiry of their retention period.
• Address queries and requests related to electronic record management systems.
• Offer training and guidance about electronic record management protocols and systems to staff.
• Issue, examine, reconcile, and archive paper logbooks following Good Documentation Practices.
• Prepare and organize documents for offsite storage and orchestrate their transfer to external storage units.
• Maintain comprehensive electronic indexes for QA procedures and methodologies.
• Assist site-wide form reconciliation efforts related to controlled forms.
• Compile document inventories and supplemental materials essential for audits and inspections.
• Collect and evaluate archive performance metrics to spot efficiency improvements.
• Identify and implement enhancement opportunities in archival, retrieval, and document management processes.
• Collaborate with various departments to ensure consistent, schedule-compliant record archiving across the site.
• Effectively communicate archive goals, progress, and key metrics to management and stakeholders.
• Support the Quality Systems team with audit preparations, inspections, metrics, and other deliverables as necessary.
• Perform additional responsibilities and undertake projects as delegated by management.

Qualifications and Experience

• Demonstrated experience in document control, records management, archiving, or comparable roles within pharmaceutical or GMP settings.
• Deep knowledge of Good Documentation Practices and handling of controlled documentation.
• Proficient with electronic document or records management systems.
• Exceptional attention to detail and precision when managing controlled records.
• Experience in providing support during audits and regulatory inspections.
• Strong organizational and coordination abilities.
• Competence in managing sensitive and compliance-critical documents confidently.
• Ability to engage productively with multiple site stakeholders.
• Analytical mindset with skills to interpret process metrics effectively.
• Capability to identify and drive procedural improvements for increased efficiency.
• Excellent verbal and written communication talents.