Job ID273386BRPosition TitleQA Specialist CGTApply to Job
Job Description
10 days! That is how long we treat a patient’s T-cells, before we return them to potentially save this patient’s live. To support such novel, personalized treatment is a unique challenge within Novartis with immediate patient impact.
The QA Specialist CGT is a member of the QA Operations Release Team that is responsible for the final release of product and overall quality oversight of the production and other operational units within Stein C> manufacturing. The team ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the operational units.
Your responsibilities:
Your responsibilities include, but are not limited to:
Support in establishing the SOP landscape relevant for QA Operations, GMP compliant BRR, Apheresis receipt and lot disposition processes during project phase.
Independent, flexible processing of all activities related to the release of product during clinical and commercial manufacturing: Technical release of primary packed and finished product, media and apheresis, evaluation and decision of deviations including robust CAPA management, review/approval of batch related quality relevant documents ( e.g. validation documents, transfer documents, APR/PQR), review/ approval of MBRs, review/ approval of executed batch records, audit and inspection support.
Minimum requirements
What you’ll bring to the role:
• Bachelor of Science or Master of Science in Biology, Chemistry, Biochemistry, Microbiology or other related science.
• Good understanding of cGMP
• Fluent English, German skills desired
• 0-5 years of experiences in pharmaceutical QA, QC or production environment;
IT-Knowledge (MS Office, SAP, Trackwise, MES)
• Ability to communicate clearly with a variety of individuals across different departments in a matrix organizationDivisionNovartis Technical OperationsBusiness UnitNTO QUALITYLocationSwitzerlandSiteStein (Säckingen)Company/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularShift WorkYes
