Msat Deviation Manager
Vor 2 Tagen
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.
**What you’ll do**:
- Initiate and manage deviation records within the Lonza QMS System (TrackWise) to ensure timely and effective resolution.
- Plan, complete, and lead Root Cause Analysis (RCA) events, engaging relevant departments and internal and External collaborators.
- Facilitate and participate in meetings to align collaborators on investigation strategy and outcomes.
- Collaborate with Cross functional teams to identify and implement corrective and preventive actions (CAPAs) to facilitate deviation closure.
- Ensure deviations and investigations are completed and closed in alignment with batch release timelines.
- Work closely with the, Operations, MSAT and Quality Assurance (QA) teams to support deviation closure and address customer-related queries with a high standard of accuracy.
- Engage in process improvement projects that improve our operational efficiency and product quality.
**What we’re looking for**:
- Master or PhD or equivalent experience in Biotechnology, Chemical Engineering or related fields
- Familiarity with cGMP regulations and quality systems.
- Good understanding of Lean Six Sigma.
- Proficient in using Track Wise or similar Quality Management Systems.
- Proven experience in performing Root Cause Analysis using effective tools and methodologies.
- Strong technical writing and communication skills, with the ability to articulate complex scientific topics and recommendations clearly.
- Outstanding organisational skills to manage multiple tasks and meet deadlines.
- Fluency in English required, German would be an advantage
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.
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