GMP Document Controller & Compliance Specialist

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

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