Sterile Quality Assurance Subject Matter Expert ( Talent Pool )

Social network you want to login/join with: Sterile Quality Assurance Subject Matter Expert ( Talent Pool ), Anagni col-narrow-left Client: Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 83f5f72632b3 Job Views: 8 Posted: 20.08.2025 Expiry Date: 04.10.2025 col-wide Job Description: 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. Are you passionate about quality and continuous improvement? Do you thrive in a dynamic, regulated environment where your expertise directly impacts patient safety and product excellence? We are seeking multiple Sterile QA SMEs to join our Quality Assurance team and take ownership of one of our core focus areas: QC Laboratories, Aseptic Production Lines, Finished Products, Intralogistics & Warehouse. If this sounds appealing, read more and apply today for a life-changing career. The Position Novo Nordisk is investing massively in new production facilities around the globe. With this expansion we will contribute with the important role of producing future products - and you will get an opportunity to be a part of it. In the position of Quality Assurance Lead, you will play a pivotal role in ensuring compliance with GMP standards, driving quality initiatives, and fostering a culture of excellence across your assigned area. Furthermore, you will: Actively participate in planning and supporting the conduction of QA activities according to quality standards and policies Support the QA oversight of external suppliers Ensure audit and inspection readiness, and participate in internal audits and regulatory inspections, as appropriate Support the development of innovative improvements to manufacturing processes. Ensure strong communication and knowledge sharing between different stakeholders on regard to Quality Assurance aspects Qualifications To be successful for this position, you have a background in pharmacy, engineering or other scientific degrees combined with at least 5 years working experience in quality assurance (QA) within pharmaceutical manufacturing industry. You have a good understanding of cGMP production, and you are knowledgeable about cGMP requirements and interpretation. In addition, you have: Working experience in sterile production and validation and qualification activities Ability to work independently and take independent decisions, create new methods and techniques by ensuring cGMP compliant processes Excellent communication and change management skills Positive attitude and a true team player Fluent English & Italian, both written and spoken On a personal level, you demonstrate a high degree of independence and decision making to ensure progress and a sound knowledge of when issues and deviations need to be pro-actively escalated to the next level. About the Department Fill & Finish Expansions (FFEx) is part of Novo Nordisk’s newly established Fill & Finish area. Our mission is to increase production capacity across the Novo Nordisk network to ensure we continue delivering high-quality products to our patients. You will join a dynamic and collaborative team that values knowledge sharing and teamwork. We work in a vibrant and positive environment where networking and cooperation are key to our success. The role is based in Anagni, where you will be part of a growing department dedicated to making a difference. J-18808-Ljbffr

Location: Anagni, Lazio, IT

Posted Date: 8/23/2025