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 and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients' lives every day, having already reached 20 million patients in over 80 countries.
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, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing 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. Join us as we continue to #discoverbetter.
What is the role?
The person in this role is responsible for supporting Quality Operations Teams to provide front-line quality support ensuring all incoming inspections, manufacturing processes, and shipping are supported from a quality and compliance perspective. Lead improvement activities within these areas to ensure all systems and processes are efficient and effective. Other activities may be assigned as needed.
What are the key responsibilities?
1. Providing MRB (Materials Review Board) system and material controls support.
2. Completion of Quality Verifications to ensure Good Document Practice Compliance.
3. Support of Manufacturing process changes and improvements including Quality Inspections at different points in the process.
4. Process Quality control to ensure all products meet its requirements prior to shipment including in-process and final inspections.
5. Complete Quality Inspections in different areas when required.
6. Corrective Action activities related to manufacturing process and systems and NC/CAPA system.
7. Trending and reporting on the Key Quality and Performance Objectives for manufacturing quality.
8. Support both the Calibration and Preventative Maintenance processes to ensure the adequate review of any unplanned activities and pieces of equipment are readily available.
9. Paperwork verifications and archiving.
10. Maintain compliance with ISO, EU MDR and FDA Quality System regulations.
11. Other duties may be assigned.
What education and experience are required?
12. Role is Parkmore based, however dependent on business needs, some travel may be required across Parkmore and Shannon sites.
13. A minimum of a certificate (Level 6) in a Quality/Science or related discipline.
14. At least two years Quality experience or related role within the medical device/pharma industry
What key skills will make you great at the role?
15. A self-starter in terms of time and task management and operate with minimal supervision
16. Strong problem-solving ability
17. Good communicator both verbally and in writing with ability to influence
18. Ability to meet deadlines
19. Good understanding of ISO 13485 and FDA QSR quality standards
20. Proficiency in use of desktop software applications such as MS Office
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. 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:
21. Excellent medical care.
22. Bonus & Pension.
23. 'Aerogen Connect' – our employee led programme which supports our global teams to unite and have fun.
24. 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 [email protected]. Please include your name and preferred method of contact.