At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Diabetes poses one of today’s biggest global health challenges. We work for a future where fewer people get diabetes, everyone with diabetes is diagnosed, and everyone who is diagnosed receives adequate treatment and can live a life with as few limitations as po...
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As the Novo Nordisk Local CMO QA areas specialist on-site at our CMO in Port Elisabeth, you will report to the QA management based in Denmark and have a close collaboration with our local affiliate based in South Affrica.
You will ensure daily QA oversight and other Novo Nordisk (NN) QA activities and be working in collaboration with team colleagues in Denmark and in India to ensure that Novo Nordisk insulin products produced in South Affrica to 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, participate 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 in topics such as equipment calibration status, data integrity, qualification and validations status as well as aseptic behaviour.
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, engineer or other relevant technical/scientific academic education complemented with a 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 from 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 an excellent written and verbal communication skills and good command of English
Yohave an understanding of cLEAN and use of it in the pharmaceutical industry
As a person you have strong quality mind-set, strong communication skills and proficient stakeholder management skills and strong inter-cultural understanding and are proficient in prioritization and execution of activities.
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