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Lonza

QA Contamination Control Manager 80-100% (f/m/d)

Reposted Yesterday
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In-Office
Visp, Valais
Senior level
In-Office
Visp, Valais
Senior level
Manage microbial control strategies within biopharmaceutical manufacturing, ensuring compliance, writing SOPs, and supporting audits and inspections.
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Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

This role is based in BioAtrium, which is a joint venture and part of Ibex® Solutions. Ibex® is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today. Apply as QA Contamination Control Manager (f/m/d)!

What you will get:

  • An agile career and a dynamic work culture.

  • An inclusive and ethical workplace.

  • Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.

Benefits in Visp: https://bit.ly/3wjkoFi  

What you will do:

  • Ensuring the development of an end-to-end microbial control concept for the biotechnological drug substance manufacturing facilities and capturing it in local documents (incl. specifications, SOPs, etc.)

  • Ensure that practices within the manufacturing facility are compliant and support microbiological control of the product

  • Ensuring a robust contamination control strategy is in place

  • Supporting the Quality Oversight on activities of Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view

  • Writing, Reviewing and approving SOPs, deviation reports and change requests, associated with the above-mentioned topics

  • Supporting the preparation and follow-up of customer audits and regulatory inspections

  • Acting as an expert during audits / inspections, presenting aspects related to the microbial control and sterility strategies

  • Enhancing the quality knowledge by following the quality standards and by visiting specific training courses / conferences

What we are looking for:

  • University degree (Bachelor/Master or PhD) preferably in Microbiology OR Pharmacy /Engineering/ Natural Science or related Life Sciences discipline

  • Substantial experience in the area of biopharmaceutical manufacturing and a strong background in cGMP

  • Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing and microbial control strategies

  • Previous Contamination Control experience, would be an advantage

  • Good communication skills and interaction with all kind of interfaces within the organization and  regulatory agencies (e.g. US FDA, EMA, etc.)

  • Working knowledge with MS Office, Excel, data trend creation/analysis, TrackWise®, LIMS and SAP is an advantage

  • Fluent English is required, German is an advantage

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Top Skills

Lims
MS Office
SAP
Trackwise®

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