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Manufacturing Documentation Specialist
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 eight-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 Manufacturing Documentation Specialist will work as part of multi-disciplinary project teams delivering on Aerogen’s core values of being mindful, responsive and expert. The role will work with the Commercial Team on Market progression and associated Compliance, with the global Commercial team to expand our product range in new geographies and directly with Aerogen’s customers to satisfy their Regularity and compliance needs.
What are the key responsibilities?
• Support Commercial project teams through the introduction of Packaging instructions, Bill of Materials (BOM) and label creation, and coordinating the document change approval process.• Collaborate with Commercial and Regulatory teams to coordinate the Manufacturing activity required to release new and existing products into new global markets.
• Work with Aerogen’s customers to update existing documentation to meet their Market and compliance requirements.
• Support training of Operators and Manufacturing personnel on changes.
• Become a subject matter expert on the creation of new labels and BOM management on ERP.
What education and experience are required?
• Level 6 in a relevant discipline.
• Minimum of 3 years of relevant experience.
What key skills will make you great at the role?
• Exceptional organizational, spelling, grammar, and typing skills.
• Proficient in the use of MS applications: Word, Excel, and PowerPoint.
• Very strong interpersonal and communication skills with a strong ability to work in a team environment.
• Strong customer service focus and proven time management skills to meet tight deadlines.
• Ability to work on own initiative, without direct supervision from management.
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:
• 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
Check out our careers website to discover more about Life at Aerogen
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 careers@aerogen.com. Please include your name and preferred method of contact.
Ireland
Engineering
Manufacturing Documentation Specialist