Switzerland, Stein

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.

Exciting opportunities at Stein, Switzerland ! Do you want to become part of a great team? The primary objective of the role is to ensure proper timing in inspection preparation for a large CAPEX project (encompassing a fill and finish facility, laboratories, warehouse, shipping and offices). You will manage qualification and validation activities to support the projects teams and objectives according to agreed deadlines and standards. Then, after the project phase, you will manage qualification and validation activities to maintain the qualified / validated status of all GMP activities necessary to maintain commercial product batch activities.

Responsibilities

You will manage quality oversight for computerized systems validation and the data integrity program & support QA activities for system introduction / upgrades, ensuring compliance with quality policies, cGMP, EU / US, and Swiss regulations. Also, you will oversee daily quality for GxP IT, CSV, and automated systems (SISA). Specifically, you will support all qualification and validation activities of computerized and automated systems (e.g. MES, PLC / SCAPA, EMS, LIMS, SAP) for DMS Lonza Stein within a project framework and in accordance with quality policies, GMP, EU / US regulations and Swiss regulations. Furthermore, you will ensure close collaboration with other site functions and you will drive compliance and continuous improvement while supporting Lonza's overall CSV and DI strategy.

Additionally, the role will require the following :

• Act as the primary QA contact for data integrity to the assigned area
• Review / approve GxP IT, CSV and SISA SOPs to ensure regulatory compliance
• Ensure compliance with cGMPs and support Commissioning & Qualification activities
• Review / approve CSV related documents, design documentation, audit trails, deviations, investigations and CAPA plans
• Align with Global QA CSV organization and support inspection readiness
• Being an actor in raising the CSV / DI maturity of the site in accordance with the group strategy
• Ensure alignment with Global QA CSV organization

Profile

Inclusion is one of Lonza’s four core values, alongside integrity, innovation and initiative. We understand the value of our differences and the benefits they bring to our company, community and culture. We also recognize the value of every person’s contribution, regardless of characteristics, preferences and beliefs – including race, color, ethnicity, sexual orientation, gender identity and religion.

Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. Depending on your location, these benefits could include family allowances, childcare support, discounts for local businesses and attractions, travel allowances and subsidized meals.

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 : R58833