Job ID295610BRPosition TitleQC Specialist (80-100%)Apply to Job
Job Description
6! The number of manufacturing sites Novartis Pharma Stein AG is supporting with bacterial endotoxin testing and monitoring of water for pharmaceutical use. As both activities are important for the manufacturing and release of (non-)sterile drug products, Novartis Pharma Stein AG is looking for a highly motivated person to support these activities as a “QC Specialist”.
Your responsibilities will include:
• Organization and facilitation of bacterial endotoxin testing & monitoring activities in accordance to good manufacturing practices and standard operating procedures for drug products, excipients & in-process-controls as well as utilities like water and gases.
• Cooperation with and support of production/ quality departments in order to optimize the quality of processes and manufactured products as well as to maintain compliance with authority requirements
• Lead the optimization and validation of analytical methods and equipment including authorship of respective documentation and operating procedures
• Mentor, facilitate and perform trend analyses on results of water analyses on a routine basis.
• Participation in multi-disciplinary teams for launch & transfer activities of (new) drug products
• Perform investigation and documentation of deviations and out-of-specification results.
• Representation of the site in customer audits & health Authority inspection
Minimum requirements
What you’ll bring to the role:
• (Technical) University degree in Life sciences, preferably in Chemistry/(Micro)biology
• Demonstrated experience in a highly regulated environment
• Know-how in quality control of drug products and monitoring of processes and facilities
• Good command in German and English
• Encourages and embraces diversity and inclusion of ideas, perspectives and cultures
• Open minded to constant improvements and simplificationDivisionNovartis Technical OperationsBusiness UnitNTO QUALITYLocationSwitzerlandSiteStein (Säckingen)Company/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularShift WorkNo
