QC Document Controller

Role overview

The QC Document Controller role focuses on creating, managing, and maintaining documentation systems within the Quality Control function. You will oversee both paper-based and electronic GMP documentation, support document control activities, and help ensure QC records are accurate, current, and properly distributed. The position reports to the QC Operations Lead and sits within a team that values respect, collaboration, and shared purpose.

Key responsibilities

• Maintain GMP documentation processes for both paper and electronic records, including the distribution and control of QC records and the rollout of quality documents within QC.
• Set up and manage the electronic and hard-copy document control system by issuing document numbers, reviewing final templates, printing master files for authors, and keeping GMP document templates up to date.
• Coordinate document effectiveness by informing relevant teams and document coordinators when documents are released.
• Handle the distribution, retrieval, and destruction of controlled documents on site.
• Update QC document registers and directories, including general, project, and audit files.
• Support the periodic review process for QC documents by preparing annual review plans, arranging document distribution, and notifying departmental coordinators.
• Track the status of QC document re-reviews, summarise review progress, and report on implementation of periodic reviews.
• Manage QC forms and notebooks, including preparation and control.
• Control and distribute QC analytical methods, specifications, protocols, and reports.
• Oversee the use and management of QC laboratory notebooks.
• Standardise document record writing and ensure requirements for second-person review are followed.
• Assist in drafting, approving, and issuing other QC quality system documents, while supporting consistency across quality management activities.
• Prepare audit packs and document lists based on daily audit schedules, and provide requested QC documents and records after audits.
• Support the preparation, revision, review, and training related to QC SOPs for document management.
• Assist with archival activities, reconciliation work, and troubleshooting around document formatting and management.
• Act as a QC subject matter expert for the EDMS from a document control perspective.
• Carry out all duties in line with GMP expectations, SOPs, and controlled documentation.
• Take on additional tasks as assigned by the Line Manager and serve as a role model for the QC function and the wider organisation through adherence to corporate values and culture.

Candidate profile

The successful candidate will bring strong document management experience, solid administrative capability, and the confidence to work effectively in a regulated QC environment. This role calls for someone who is organised, proactive, and comfortable working across teams to keep documentation compliant and well controlled.

Requirements

• Strong Microsoft Office skills, especially Word, Excel, and PowerPoint.
• Excellent organisational ability with effective prioritisation and a strong sense of efficiency.
• Ability to plan ahead, identify issues early, and resolve problems accurately and promptly.
• Clear communication and strong interpersonal skills.
• At least 3 years of experience in a fast-moving work environment.
• Prior experience in a GMP setting, particularly in a documentation-related role, is preferred.
• Experience with brownfield or greenfield facility start-up projects is an advantage.
• Knowledge of or experience in GMP pharmaceutical site operations would be beneficial.
• A diploma or degree is desirable.
• Collaborative, inclusive, and team-oriented working style.
• Strong problem-solving and troubleshooting capability.
• Flexible, positive, and able to work well within a team dynamic.
• Comfortable working cross-functionally with site teams.
• Self-directed, proactive, and able to use initiative to move actions forward.
• High ethical standards with a strong commitment to company procedures, policies, regulatory expectations, and customer requirements.

Additional information

This is a full-time onsite role based in Dundalk, County Louth, Ireland. Applications close on Wednesday 15th April at 5:00 pm. The employer is an equal opportunities employer. The role is part of a global organisation focused on growth, change, and building a shared future.

Working style and environment

You will be expected to work in line with GMP requirements and controlled procedures, support cross-functional collaboration, and contribute positively to the QC function and the broader site culture.

Organisation values

The company emphasises respect for people from all backgrounds and experiences, teamwork, strong ethics, and a culture of integrity and accountability.