QA CSV&Equipment qualification QC

at  Lonza

QA CSV & QUALIFICATION FOR LABORATORY EQUIPMENT

Switzerland, Visp

JOB DESCRIPTION SUMMARY

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.
Equipment used for the analysis of chemical and biological products has to be properly tested and is released/approved by authorized people for its intended use. The increasing computerization of laboratory equipment adds complexity. The corresponding systems require a computerized system validation to cover risks as data integrity or ensuring the correct equipment/software parameters.
The QA Specialist CSV & Qualification (m/f/d) will be part of a team that is currently established to release laboratory equipment for QC activities.
He/She represents the Quality Assurance Unit, releases Deviations that arise during qualification or the life cycle of the equipment, helps to assess the impact on products and helps to define appropriate CAPA(s) as solutions.

Key responsibilities:

• Controls, approves/releases computerized system validation documents by following regulatory guidelines and local operating procedures
• Controls, approves/releases qualification documents by following regulatory guidelines and local operating procedures
• Approves/releases equipment related Deviations
• Ensures cGMP compliance
• Supports the business through ongoing change and process improvement activities.

Key requirements:

• Bachelor or Master degree in IT, chemistry, biotechnology, life science or related field.
• Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.
• Knowledge of biotech. manufacturing processes and analytical methods is an advantage.
• Experience with Human and Organizational Performance & risk management approaches is an advantage
• Fluency in German, both written and spoken. English is an advantage.
• Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.
• Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.
• Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.

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.

• Controls, approves/releases computerized system validation documents by following regulatory guidelines and local operating procedures
• Controls, approves/releases qualification documents by following regulatory guidelines and local operating procedures
• Approves/releases equipment related Deviations
• Ensures cGMP compliance
• Supports the business through ongoing change and process improvement activities