Octapharma ist auf die Entwicklung und Herstellung von hochreinen Arzneimitteln aus menschlichem Blutplasma spezialisiert. Als Teil eines Familienunternehmens ist Octapharma Wien nicht nur der größte Produktions-, sondern auch ein erfolgreicher Forschungsstandort der Octapharma Gruppe. Da unser Standort laufend wächst, suchen wir ab sofort zur Verstärkung unseres Teams: 1 Quality Assurance Associate (m/f/d) - Corporate Drug Safety Your new challenges which will inspire you: -Assistance in the implementation and maintenance of a comprehensive GVP compliant quality program -Maintenance and development of the Octapharma drug safety SOP system -Assistance with the initiation, writing, review, approval, update, and distribution of documents e.g. policies, SOPs, and associated documents -Maintenance and development of the Octapharma drug safety training system -Maintenance and development of the Octapharma drug safety deviation management system and CAPA plan -Training and ongoing qualification of local drug safety personnel Management of external safety relevant network -Compliance and deviation management of the drug safety system at Octapharma -Development and maintenance of the Octapharma Pharmacovigilance System Master File -Preparation, execution, post-processing of authority PV inspections, preparation of inspection report and coordination of action plans -Planning, conduct and follow up of drug safety audits Your profile that will convince us: -Completed academic degree, ideally in a medical, life science or healthcare discipline -Pharmacovigilance knowledge and experience in quality assurance related to drug safety would be an advantage -Working knowledge of GVP, GCP and ICH and how they interface with other GxPs -Very good verbal and written English skills as well as communication and presentation skills -Team player with a strong focus on timelines -Good level of computer literacy, in particular in the use of databases -Commitment and ability to handle high workloads and deadlines -High degree of accuracy with attention to detail -Excellent critical, analytical and problem-solving skills Our attractive benefits for you: -Wide range of tasks in an international setting, flexibility and personal responsibility -Reliable employer with generous employee benefits and a salary customary in the market. -Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more: Additional information: The minimum gross salary according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed. We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life - because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal. Further informations you can find on Das Mindestentgelt für die Stelle als Quality Assurance Associate (m/f/d) - Corporate Drug Safety beträgt 3.909,67 EUR brutto pro Monat auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.
Quality Assurance Associate (m/f/d) - Corporate Drug Safety