QA for QC Manager

vor 4 Wochen

Visp, Schweiz Lonza Vollzeit

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.

Key responsibilities:

  1. Define and approve specifications for raw materials, in-process samples, and APIs, including related documents.
  2. Review and approve SOPs, analytical methods, sampling protocols, assessments, equipment qualification, and method validation plans/reports from the QC department.
  3. Approve Out-of-Specifications/-Expectations protocols, review associated raw data, and oversee deviation investigations in the QC area.
  4. Write, revise, and own SOPs within the area of expertise, ensuring compliance with quality standards.
  5. Represent QA in relevant project organizations and contribute expertise in technical transfers.
  6. Ensure proper application of change management processes for analytical methods and specifications, including validation and qualification activities.
  7. Drive CAPA and Effectiveness Check items to completion and ensure timely closure.
  8. Conduct internal and external audits, and support customer audits and health authority inspections.

Key requirements:

  1. Bachelor, Master, or PhD in chemistry, biotechnology, life sciences, or a related field.
  2. At least 3 years of experience in the pharmaceutical industry, preferably in QC or QA, with strong analytical expertise and experience in method validation.
  3. Solid background in cGMP regulations, including USP, European, and Japanese Pharmacopoeia, with auditing experience and interactions with health authorities (e.g., FDA, Swissmedic).
  4. Solution-oriented, team-minded, and able to oversee project execution to ensure compliance with quality standards.
  5. Structured, well-organized, and open to new ideas, with an agile and dynamic approach.
  6. Excellent verbal and written English skills; German language knowledge is 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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