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Novartis QA Manager & Responsible Person

Novartis

Novartis

Quality Assurance
Hungary
Posted on Wednesday, January 24, 2024

About the Role

99 million. That’s how many lives our products touched in 2023.

Novartis is the number one innovative company in Hungary, and this is your opportunity to join us as the QA (GDP) Manager, Responsible Person particularly focusing on Radiopharmaceuticals. In this role you will release Novartis medicinal products according to the GDP regulations, you will always have to have reliance on the final sample / withdrawal / suspension notifications on the NNGYK, former OGYÉI website. As Deputy of Radiosafety Officer Person you will be solely acting in Novartis Hungary Ltd. according to the local legal requirements and be responsible for release for distribution of Radiopharmaceuticals (radioisotope labeled medicinal products), handling product related documents and informing the specific wholesaler by preparing and issuing the necessary radiosafety certificate intended for product release.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Quality oversight of the work in the Novartis warehouse area according to GMP and GDP Guidance in compliance with the local regulations related to the activity. This includes inspecting the sampling process, qualification, and release of registered medicinal products entering the warehouse, and in the case of non-compliant products: the blocking of these products in the computerized system (SAP)
• Manage quality certificates electronically signed by the EU Qualified person of Novartis to be sent to wholesale partners; keep records of suppliers and customers and regularly review them; approve the change / validation / qualification documents for all significant changes in the wholesaling process
• Maintain appropriate documentation and checking of the temperature recorders (data loggers) applied during delivery and wholesale in-and out-bounding; Also responsible for initiating and supervising product recall: implement necessary measures in case of recall and product suspension; handle customer complaints and quality complaints in close collaboration with Novartis Complaint Manager and Complaint Hub
• Follow the changes in the regulations affecting respective field. Prepare and review quality assurance regulatory documents in the field of regulation of activities related to pharmaceutical wholesale activities; participate in professional GMP/GDP/ISO trainings and perform GMP/GDP/ISO trainings
• Report, investigate and document any discrepancies related to the wholesaling and warehousing activity of the medicinal products subject to the Hungarian market; manage annual self-inspection plan, participate in their implementation; preparation for and active participation in official Authorities (e.g. NNGYK) inspections (especially with regard to radiopharmaceuticals), participate in external audits if necessary
• Handle formally defective HA permits (so called faulty sample permits), final sample permits, contact the responsible quality assurance and Regulatory Affairs of Novartis Hungary Ltd.; receive, inspect, qualify and release printed packaging materials and concerning units subject of modification with the permission of NNGYK. Approve the packaging order of these preparations to be modified - review of the packaging documentation, control of the repacked/modified units and their packaging material provided by our third party packaging plant.



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