Junior/ QA Manager IBEX™ (f/m/d)

Switzerland, Visp

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

In Visp we are looking for a  Junior/ QA Manager IBEX™ to extend our team. You will report to the QA Group Leader Batch Review IBEX™, work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant mRNA manufacturing activities and documentation within IBEX™

Key responsibilities:

  • Perform the daily BI tool and MPS tracking as a Power BI user.

  • Track, follow up and update status for EM report, TSE/BSE reports, Change assessments, BRR etc.

  • Coordinate and lead customer communication for mRNA batch review activities using specialized SharePoint tools.

  • Review of completed batch and / or cleaning logs, including data such as device printouts, temperature charts, test procedures, raw QC data and logbooks, to ensure that cGMP manufacturing activities have been performed and documented in accordance with approved written procedures

  • Support Improvement and EBR implementation initiatives.

  • Support conditional and full batch release by ensuring the completeness of the documentation package

  • Review comments added to the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks), clarify with the operations team and evaluate with the responsible QA Manager

  • Support the initiation of deviations and investigations for Batch Record review related observations

  • Collect and evaluate on a regular basis KPI data

Key requirements:

  • Has solid understanding of BI Tool and MPS tracking, and prior experience as Power BI user is preferred.

  • Experience in tracking EM and TSE/BSE reports.

  • Experience in cross functional team and customer communication for mRNA batch review activities.

  • Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field.

  • Knows the concept and experience on good documentation practice

  • Understands the TrackWise, SAP, LIMS, Sharepoint, BI Tracking and Microsoft Office systems

  • Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate to

  • Ability to identify non-compliance and gaps from quality standards

  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

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Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R34840