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Apply to JobJob ID251163BRPosition TitleSenior AS&T SpecialistJob DescriptionStein is a site of strategic importance for the manufacturing and launch of innovative medicine. One of the most important pharmaceutical production plants of Novartis Technical Operations is located in Stein: The plant Stein Steriles. The site is launch site & center of excellence worldwide for innovative sterile drug products for injection containing Biologics as well as manufacturing site for clinical supplies of sterile dosage forms required in global clinical studies.



The Senior AS&T Specialist provides support on any topic related to analytical equipment including qualification and troubleshooting. The focus lies on the initial identification, purchasing and qualification of suitable and efficient analytical equipment. Furthermore, he/ she leads and supports global initiatives with respect to analytical equipment and related topics.



The main accountabilities are the following:



• First point of contact for internal local customers

• Lead/ support of global and or local initiatives related to analytical equipment

• Author of equipment qualification documentation

• Administrator role for analytical equipment

• Audit and inspection support

• Support for equipment troubleshooting

• Investigation of equipment related deviations

• Coordination of remediation plan and qualification activities

• Supervising Lead Lab activities

• Monthly reporting of maintenance KPI for QC and AS&T

Minimum requirements• University degree in pharmacy or chemistry or equivalent

• Fluent in German and English (spoken/written)

• Several years of experience in pharmaceutical quality control and/or quality assurance

• Good knowledge of GMP and stability guidelines (ICH Q1, etc.)

• Good computer knowledge (MS Office, Notes, documentum, etc.)DivisionNovartis Technical OperationsBusiness UnitNTO QUALITYLocationSwitzerlandSiteStein (Säckingen)Company/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular

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