QA Specialist Operations (f/m/d)

☞ Lonza

View: 170

Update day: 10-04-2024

Location: Visp Valais VS

Category: Sales Pharmaceutical / Chemical / Biotech Consulting / Customer Service Information Technology

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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.

Currently we are looking for a QA Specialist Operations (f/m/d), who will mainly be responsible for deviations and / or similar quality records, as part of a middle sized team of quality experts.

Key responsibilities:

  • Close collaboration with Quality Control and Production department on deviations and other quality records

  • Supporting with investigations and collaborating with customers, including leading customer agreement meetings to manage the process for notifying the customer about discrepancies / change requests and assuring the customer’s feedback and relevant comments are addressed internally

  • Review and approve SOPs and documentation for Quality System; support and approve quality risk analysis (e.g. FMEA). Write or revise SOPs in area of expertise and act as Owner of such documents

  • Being involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department

  • Being involved in transfers of manufacturing processes. Maintain contact with customers, facilitate discussions between customers and internal teams such as MSAT (Manufacturing Science & Technology), Manufacturing, Engineering and Quality Control

Key requirements:

  • Bachelor in Biotechnology, Biology, Chemistry or other natural science

  • Significant experience in an GMP regulated environment; preferable within Quality Control (QC) of biopharmaceutical manufacturing

  • Broad knowledge of biotechnological manufacturing processes

  • Knowledge or experience in the usage of lab-software (iLAB, TrackWise, LIMS) would be an advantage

  • Fluency in English, 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.

Reference: R55087
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Deadline: 25-05-2024

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