Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team: 1 Computer System Validation Specialist - Corporate Drug Safety (m/f/d) Your new challenges which will inspire you: -Be part of a successful international pharmaceutical company -Work in Computer Systems Validation Projects under application of GxP guidelines -Work in the area of pharmacovigilance and partner with drug safety specialists -Create, execute and/or review IT system qualification and validation related documentation -Assess and/or author change control, incidents, deviations and investigations related to computer systems -Create or contribute to computer validation related SOPs -Participate in software life cycle management -Act as or support system administrator of drug safety IT application(s) -Communicate with software suppliers and IT help desk -Participate in authority inspections and audits Your profile that will convince us: -Degree in bioinformatics, computer science or degree with strong IT background or several years of professional experience in a comparable position in the pharmaceutical industry -Very good level of computer literacy -Deep understanding of relational database management systems and expertise in understanding and creating SQL queries -Knowledge of MS Access and Visual Basic for Application (VBA) is a plus -Experience with data reporting and report creation as well as risk evaluation and software testing is a plus -Experience in the plasma or pharma industry or any other highly regulated industry as well as GxP related IT projects is a plus -Knowledge of 21CFR part 11, EU-GMP Annex 11 and other regulations is a plus -Knowledge of ARISg, LSMV systems is a plus -Strong verbal and written communication and documentation skills (English and German) -Strong organizational skills -High level of accuracy with attention to detail as well as analytical skills -Proactive personality with a high degree of accountability -Team player 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 wage according to the collective agreement (chemical industry) for your new job is EUR 3.557,47. 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. Fore more information, please visit Das Mindestentgelt für die Stelle als Computer System Validation Specialist - Corporate Drug Safety (m/f/d) beträgt 3.557,47 EUR brutto pro Monat auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.
Computer System Validation Specialist - Corporate Drug Safety (m/f/d)