QA Specialist, Cell & Gene Therapies (CGT)

    • Bad Säckingen, Germany

Job Description
10 days! That is how long we treat a patient's T-cells, before we return them in order to potentially save this patient's live. To support such novel, personalized treatment by ensuring application of correct artwork, is a unique challenge within Novartis with immediate patient impact.

The QA Specialist is a member of the QA Analytics & Aseptics Team in QA Operations that is responsible for the final overall quality oversight of the production, Quality Control and other operational units within Stein C & GT manufacturing. The QA Operations 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:

• QA Oversight of CGT Quality Control (QC) Unit. This includes QA for release analytics of media and finished product, e.g. FACS, qPCR, ELISA, beads and virus analytics.
• QA Oversight of CGT Manufacturing Unit/shopfloor with regard to aseptic topics, e.g. hygiene, aseptic working technique, environmental monitoring, best practice in clean rooms.
• Writing, review and/or approval of validation and qualification documents (plans and reports), Out of Specification records, Deviations and other Quality Events, Change Requests, SOPs, risk assessments, testing monographs, transfer documents, lab protocols, trending reports, annual reports, stability reports, certificate of analysis (CoA).
• Be point of contact regarding QA questions in quality control and aseptic questions in manufacturing unit, provide ad hoc decisions and act as trainer and advisor on aforementioned topics.
• Participate and key person in health authority and internal inspections.

Minimum requirements
What you'll bring to the role:
• 2-5 years of GMP/GxP experience in pharmaceutical QC, QA, MS&T or production environment, preferably in sterile manufacturing or Cell & Gene (ATMPs)
• Strong knowledge and expertise in Quality Control and Aseptics
• Strong written and verbal communication skills, ability to communicate clearly with a variety of individuals in various aspects of Novartis operations (QA, QC, PU, MS&T, Logistics)
• IT-Knowledge (MS Office, SAP, Outlook, Trackwise, LIMS)
Desirable requirements:
• BA or MS in Cell/Molecular Biology, Genetics, Biochemistry, Microbiology or related discipline
• Fluent in German, good working knowledge in English

Why consider Novartis?

750 million. That's how many lives our products touch. And while we're proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help reimagine medicine.We are Novartis. Join us and help us reimagine medicine.

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