Local CMO QA Area Specialist

Are you passionate about improving patient lives? Do you have a strong desire to be part of a patient-centric company and to ensure the highest quality products? If you are ready for a life-changing career, apply now to join our dynamic team at Novo Nordisk South Africa, a leading innovator in the pharmaceutical industry, as a Local CMO QA area specialist to make a difference in the lives of patients. The position is based in Port Elizabeth and will report to the Novo Nordisk Global Contract Manufacturing Quality management.
Apply today and get a life-changing career!

The position
As the Novo Nordisk Local CMO QA areas specialist on-site at our CMO in Port Elizabeth, you will report to the QA management based in Denmark and have a close collaboration with our local affiliate based in South Africa. You will ensure daily QA oversight and other Novo Nordisk (NN) QA activities and work in collaboration with team colleagues in Denmark and India to ensure that Novo Nordisk insulin products produced in South Africa for local and global markets are in compliance with requirements in Novo Nordisk specifications, quality agreement, local requirements, and EU GMP. Your other responsibilities will be to:

• Review and status assignment of batch documents for manufactured products and release for marketing.
• Handle deviations, change requests, etc., occurring during local manufacturing.
• Quality Assurance Oversight; Daily QA oversight at the local facility including frequent shop floor presence. Oversight of batch-related activities such as batch release, participation in on-site full batch review, parallel batch review activities, process activities, and Product Quality Review.
• Quality Assurance presence at the CMO facility, warehouse, manufacturing, and packaging lines. Perform periodic checks and spot checks on topics such as equipment calibration status, data integrity, qualification and validations status, as well as aseptic behavior.
• Support manufacturing projects when expanding and improving production capacity and quality. Preparation of project-related documents. Quality assurance (QA) presence during project activities.

Qualifications
You hold a University Degree/Diploma or equivalent in Pharmacy, engineering, or other relevant technical/scientific academic education complemented with continuous further education within the relevant professional subjects, quality assurance, GMP, and within the resource area. You have at least 8 years of experience within aseptic manufacturing and preferably experience in quality assurance. You have a thorough knowledge of EU GMP and some international experience. You have extensive qualifications within deviation/investigation handling and change request handling within aseptic manufacturing. Furthermore, we expect that:

• You have excellent written and verbal communication skills and a good command of English.
• You have an understanding of cLEAN and its use in the pharmaceutical industry.
• As a person, you have a strong quality mindset, strong communication skills, proficient stakeholder management skills, and strong inter-cultural understanding, and are proficient in prioritization and execution of activities.

About the department
You will be part of Global Contract Manufacturing Drug Product. We are the part of Novo Nordisk responsible for manufacturing Novo Nordisk drug products from Contract Manufacturing Organizations around the world. Together with more than 260 colleagues, you will be ensuring medicine to more than 6 million patients. Our area is growing and will over the coming years deliver products to significantly more patients and will consequently expand our CMO network as well as product portfolio.

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
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Deadline
5 January 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 the communities we operate in. Together, we’re life-changing.