Document Control Administrator- ERP

Aerogen; Galway; Hybrid; EUR 40,000 - 55,000; Full time

Benefits offered by this job

Excellent medical care.

Bonus & Pension.

Aerogen Connect

Job summary

Aerogen, based in Galway, is seeking a Document Control Administrator-ERP to manage the Document Control System, coordinate DCRs, and ensure compliance for the ERP Transformation project. You will maintain Q-Pulse or an equivalent eQMS, support audit readiness, and handle archival activities.

Strong attention to detail, data entry skills, and excellent communication are essential. This role offers a collaborative, quality-driven environment with opportunities to contribute to regulatory

Qualifications

• Certificate or diploma in Quality Assurance or equivalent industrial with the medical device industry, with at least 2 years in QA or related role.
• Excellent verbal & written communication skills.
• Detail oriented and well-organised.
• Data Entry Skills.
• Record, filing & archiving management skills.

Responsibilities

• Coordinate the DCR process and ensure ongoing compliance for the ERP Transformation project.
• Ensure all project deliverables meet regulatory documentation standards and are audit ready.
• Responsible for Q-Pulse or alternative eQMS Document Management System, including development and improvement projects.
• Handle all administrative activities to support Document Control and Quality Records Storage for the ERP Transformation project.
• May assist or perform internal audits and assist in preparation for external audits as required.
• Assist with ERP Transformation project as necessary.

Skills

Document Control

ERP

Regulatory Compliance

Communication Skills

Attention to Detail

Data Entry

Record Filing & Archiving

Education

Certificate / Diploma in Quality Assurance

Tools

Q-Pulse

eQMS

MS Word

Excel

Job description

About Aerogen:

Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and twelve-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries.

Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work.

We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes.

Our business continues to grow rapidly across the globe and, as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.

What is the role?

Document Control System administration & management through processing of required changes as per the current processes and system. Co-ordination of workflow & prioritization including capture of relevant metrics.

What are the key responsibilities?

• Responsible for the Document Control System, including co-ordination of DCR process & ongoing compliance for the ERP Transformation project.
• Ensure all project deliverables meet regulatory documentation standards and are audit ready.
• Responsible for the Q-Pulse Document Management System (or alternative eQMS Document Management System as appropriate), including development and improvement projects as applicable.
• Handle all administrative activities to support Document Control and Quality Records Storage for the ERP Transformation project.
• May assist or perform internal audits & assist in preparation for external audits as required.
• Assist with ERP Transformation project as necessary.

Key Deliverables to include:

• Approved and traceable ERP documentation.
• Audit-ready compliance documentation package.
• Status reports on compliance risks/issues to ERP Steering Committee.

What education and experience are required?

• Certificate / Diploma in Quality Assurance or equivalent industrial with the medical device industry, of which at least 2 years must be within a quality assurance or related role.
• Excellent verbal & written communication skills.
• Detail orientated & well- organised.
• Data Entry Skills.
• Record, filing & archiving management skills.

What key skills will make you great at the role?

• Proven track record in Document Control for enterprise-level systems in a regulated environment, ideally ERP.
• Ability to work within a team environment to achieve agreed ERP Transformation Project and company goals.
• Ability to communicate effectively with all levels of the company.
• Ability to meet deadlines.
• A good understanding of EN ISO 13485, MDSAP & FDA requirements.
• Proficiency in the use of desktop software applications – MS Word, Office, Excel.
• Excellent planning and co-ordination skills.
• Excellent verbal and written communication skills.
• Excellent attention to detail.
• Excellent ability to communicate quality/regulatory concepts effectively.

  What is it like to work at Aerogen?

  Our purpose is to transform patients' lives and innovation is embedded in our culture. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:

  • Excellent medical care.
  • Bonus & Pension.
  • ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.

  We pledge 1% of profits and time to charities and organisations.

  Aerogen is committed to promoting diversity, inclusion and equality in the workplace.

  If you have any difficulty using our application process, please contact us by emailing [e-mail]. Please include your name and preferred method of contact.

  Job Title

  Document Control Administrator- ERP

  Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications.