Document Controller

Morgan McKinley; Galway; On-site; EUR 42,000 - 62,000; Full time

Job summary

Morgan McKinley is seeking a QA Document Controller in Galway to manage day-to-day administration, distribution, archiving and maintenance of GMP documentation at the client site. You will ensure SOPs, batch records, technical protocols and training records comply with EU/FDA GxP standards, with a focus on EDMS, QMS and data integrity.

The role is full-time and onsite five days per week. Responsibilities include supporting internal audits (HPRA, FDA), tracking document lifecycle, and

Qualifications

• Diploma or Bachelor's degree in Science, Engineering, Business, or related discipline.
• 2+ years of documentation control or QA administration in regulated pharma/medical device.
• Strong knowledge of cGMP, GDP, and data integrity.

Responsibilities

• Document Life Cycle Management: Coordinate creation, review, approval, revision, and retirement of site documents using EDMS.
• Quality & Compliance Oversight: Ensure workflows comply with QMS, Annex 11 / CFR Part 11 and ALCOA+.
• Archiving & Retrieval: Maintain archives and enable fast retrieval during audits (HPRA, FDA).
• Training Administration Support: Act as local admin for LMS, tracking document-driven training.
• Continuous Improvement: Track change controls, identify bottlenecks, issue KPI reports.

Skills

Documentation Control

Quality Assurance

Regulatory Compliance

GxP Knowledge

Process Improvement

Education

Diploma or Bachelor's degree in Science, Engineering, or related discipline

Tools

Veeva

TrackWise

Documentum

MasterControl

LMS

Job description

The QA Document Controller will manage the day-to-day administration, distribution, archiving, and maintenance of Good Manufacturing Practice (GMP) documentation at the clients site. This role ensures all Site Standard Operating Procedures (SOPs), batch records, technical protocols, and training records adhere to strict EU/FDA GxP regulatory standards.

Key Responsibilities

• Document Life Cycle Management: Coordinate the creation, review, approval, revision, and retirement of site controlled documents (SOPs, Work Instructions, Forms, Batch Execution Records, Specifications) using Electronic Document Management Systems (EDMS).
• Quality & Compliance Oversight: Ensure all document workflows strictly comply with site Quality Management System (QMS), Annex 11 / CFR Part 11 Data Integrity, and ALCOA+ principles.
• Archiving & Retrieval: Maintain physical and electronic document archives. Manage secure record retention schedules and enable fast retrieval of records during internal, customer, and regulatory audits (e.g., HPRA, FDA).
• Training Administration Support: Act as local administrator for the Quality Management and Learning/Training platforms (e.g., electronic LMS), tracking document-driven training workflows prior to effective date implementation.
• Continuous Improvement: Track document change controls, identify workflow bottlenecks, and issue monthly KPI reports on review timelines and document aging.

Key Requirements

• Education: Diploma or Bachelor's degree in Science, Engineering, Business, or a related discipline.
• Experience: 2+ years of documentation control or QA administration experience within a regulated Pharmaceutical or Medical Device environment.
• Technical Skills: Hands-on experience with EDMS software (e.g., Veeva, TrackWise, Documentum, MasterControl) and Learning Management Systems (LMS).
• Regulatory Knowledge: Sound understanding of cGMP principles, GDP (Good Documentation Practice), and data integrity guidelines.
• Location & Work Schedule: Ability to work full-time (5 days per week) onsite