Computer System Validation Quality Assurance

Computer System Validation Quality Assurance (CSV QA) Specialist

**Category**:Quality

**Location**:Anagni, Lazio, IT
- 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.
- At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

**The Position**
- As a Computer Systems Validation QA Specialist, you will approve validation strategies and plans for GMP computerized systems in accordance with regulatory requirements (FDA, EMA, etc.), and support in determining the level of validation required. You will conduct and review risk assessments to identify potential risks associated with computerized systems and develop risk mitigation strategies.
- Furthermore, you will:
- Approve and review CSV documentation, ensuring all validation activities are properly documented and comply with regulatory guidelines and internal procedures.- Support IT in conducting investigations for CSV deviations, when required.- Conduct periodic reviews and audits of computerized systems to ensure compliance with regulatory requirements, industry standards, and internal policies.- Review and approve UAR and ATR programs for all IT GxP systems based on the yearly plan.- Coordinate and execute software vendor audits and provide support during regulatory inspections

**Qualifications**
- To be successful in this role, you have an University degree in Engineering or any relevant field a minimum of 3 years of experience in computer system validation You have Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GAMP 5).
- In addition, you have:
- Experience in validating computerized systems used in pharmaceutical manufacturing environment.- Knowledge of validation methodologies, risk assessment techniques, and validation documentation practices.- Good stakeholders management skills- Fluent English and Italian, both written and spoken

**About the Department**
- Located in Anagni, our department is dedicated to managing and supporting the organization’s information technology resources. We focus on defining and executing validation and qualification strategies for GxP Computerised Systems, Computerised Equipment, Infrastructure, and Emerging Technologies such as AI and ML. Our team is responsible for ensuring compliance with internal and external regulatory requirements, participating in audits, and finding solutions to compliance gaps. Join a dynamic and innovative team committed to excellence and continuous improvement.

**Working at Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we
- seize them. From research and development, through to manufacturing, marketing and sales - we’re all working to move the needle on patient care.

**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.