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.As a QA Validation Specialist, you'll play a critical role in ensuring the integrity and compliance of our products from the very beginning. If you are passionate about quality assurance in the pharmaceutical industry, we want to hear from you!Join Novo Nordisk, a global leader in diabetes care, and be a pivotal part of our commitment to quality and innovation!The PositionYour main responsibilities, will be:Conduct a comprehensive review of all equipment qualification activities and process validationMonitor QA milestones, assist in issue resolution, and interact effectively with internal and external stakeholders for risk mitigation.Collaborate in the preparation and execution of pre-approval inspections for approval of new departments and customer audits for new product introductions.Review and manage all documentation related to Quality Assurance activities, including Master Batch Records and procedures.Ensure compliance with GMP during batch releases and support investigations of deviations as necessary.QualificationsAs our ideal candidate, you have a bachelor’s degree in life science and a minimum of 5 years of experience in quality assurance, focusing on Quality Operations and Qualification/Validation activities for sterile production (Vials and Pre-Filled Syringes).In addition, you have:In-depth knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) related to Sterility Assurance and Qualification/Validation activities.Strong understanding of pharmaceutical quality management systems.Experience in sterile manufacturing would be highly appreciatedDiversified experience across different functional areas and/or quality.Advanced and fluent English skills.Management and leadership skills aimed at enhancing organizational synergies.Robust knowledge of manufacturing processes, products, documentation, and procedures.Working at Novo NordiskAt 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.ContactIf you believe you are qualified, and cannot wait to take the challenge, please upload your CV directly via our online application tool.DeadlineApply before June 9th, 2025 .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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