Document Control Lead – QMS & Compliance

Aerogen; Galway; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Excellent medical care

Aerogen Connect employee program

1% charity/miles donation

Job summary

Aerogen, headquartered in Galway, Ireland, is a global leader in acute care aerosol drug delivery. We are seeking a Document Control Specialist to administer and manage the document control system, coordinate workflows, and capture metrics.

This role supports Quality, Regulatory, Engineering, and Operations across our expanding global team. The successful candidate will maintain QMS records, ensure current versions are available, and assist with audits and change control in a fast-paced,

Qualifications

• Diploma or Bachelor's Degree in Business Administration, Quality, Information Management, or related discipline.
• 2+ years' experience in a document control, quality administration, or records management role.
• Experience with document management systems and Microsoft Office applications.
• Strong understanding of document control principles (ALCOA++), version control, and records management.
• Understanding of EN ISO 13485, MDSAP, MDR, QMSR requirements.

Responsibilities

• Maintain the organizations document control system and ensure all controlled documents are accurately recorded.
• Manage document creation, review, approval, revision, distribution, and archival processes.
• Ensure only current approved versions of documents are available for use.
• Maintain indexing, filing, and retrieval systems.
• Facilitate document updates and revisions with document owners and departmental stakeholders.
• Archive obsolete documents in accordance with retention requirements.
• Support internal and external audits by providing documentation and records as required.
• Monitor document review schedules and facilitate periodic reviews.

Skills

Administrative skills

Attention to detail

Multitasking

Communication

Education

Bachelor's Degree in Business Administration

Bachelor's Degree in Quality/Information Management

Tools

Document management systems

Microsoft Office

Job description

Aerogen, headquartered in Galway, Ireland, is a global leader in acute care aerosol drug delivery. We are seeking a Document Control Specialist to administer and manage the document control system, coordinate workflows, and capture metrics.

This role supports Quality, Regulatory, Engineering, and Operations across our expanding global team. The successful candidate will maintain QMS records, ensure current versions are available, and assist with audits and change control in a fast-paced,