Expert Science & Technology, Qualification Expert (f/m/d)
Novartis
Job Description Summary LOCATION: Schaftenau, Austria
ROLE TYPE: Hybrid Working, #LI-HybridWith over 200 programs in clinical development at Novartis at present and many of these including new molecular entities as well as additional indications and different formulations for marketed products we are creating medicines that could significantly advance treatment standards for patients worldwide.As such we are seeking an Expert within Science& Technology to be a Qualification Expert as we continue to advance our programs.Please watch the following video for more information about what we do:
https://www.youtube-nocookie.com/embed/ggbnzRY9z8wJob DescriptionKey responsibilities:Your responsibilities include, but are not limited to:Qualification of analytical equipment, temperature-controlled storage cabinets and cold rooms in a Good Manufacturing Process (GMP) regulated environmentEstablish and drive qualification of complex state-of-the art analytical instruments (e.g. Mass Spectrometry) and related softwareRepresent department in local and global initiatives related to equipment and software qualificationLead implementation of digital systems and represent the local and global organization in global teamsCreate and execute qualification, calibration and maintenance plansPerform GMP risk assessmentsProvide technical trouble shooting during Performance Qualification (PQ) and validationInvestigate deviations related to analytical equipment and temperature-controlled storage cabinets and cold roomsREQUIREMENTS:Essential:Master’s degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years strong relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry in an GMP regulated environmentProficiency in English (and German is beneficial)Good knowledge analytical equipment qualificationProven experience within GMP environmentGood theoretical and scientific knowledge in the area of expertise (like high performance liquid chromatography (HPLC), Capillary electrophoresis (CE) etc.)Desirable:Knowledge in SAP and LIMS applicationStrong knowledge using digital system for planning and execution of equipment qualificationA personality with a can-do mind-set and the ability to adopt to change with strong communication across organizational interfaces and presentation skillsAbility to work and lead (a cross-functional team) in a matrixYou’ll receive:You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Österreich
Wed, 26 Mar 2025 05:40:03 GMT
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