Equipment Qualification Specialist

31 lug - Anagni
Novo Nordisk

Equipment Qualification Specialist **Category**:Engineering & Technical **Location**:Anagni, Lazio, IT **The Position**
- In this role, you will ensure the execution of qualification activities for equipment/utilities/systems which is crucial to maintain high production quality in line with GMP regulations and NovoNordisk standards. Reviewing technical documentation and establishing qualification strategies based on risk assessments will be your key responsibilities.
- Additionally, you will: - Coordinate external consultants and schedule qualification tasks
- Develop and revise the qualification documentation (IOPQ protocols, Final Report, Risk assessment) and execute the qualification tests
- Aid in upholding the qualification status of systems, equipment, and utilities
- Engage with suppliers and collaborate with customers to exchange qualification methodologies
- Play an active role in regulatory and customer audits
- Your role is pivotal in upholding quality standards and compliance, contributing significantly to the smooth functioning of operations. **Qualifications**
- To excel in this role, a university degree in Chemistry, CTF, Biology, Biotechnology, or Chemical Engineering is essential, along with 3-5 years of experience in Equipment/utilities/system validations, preferably within the pharmaceutical manufacturing sector.
- In addition, you have: - Fluent English, both written and spoken
- Good knowledge of production processes and management systems
- Strong communication skills,



to efficiently interact with different stakeholders **About the Department**
- End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients. You will be part of a global team that will develop the pharma facilities of the future and work with advanced technology to rethink our fill & finish facilities. **Working at Novo Nordisk**
- We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. **Contact** **Deadline**
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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