QA Expert Equipment Qualification and Validation, CSV

vor 3 Wochen

Stein, 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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as QA Expert Equipment Qualification and Validation, CSV and DI 80-100% (m/f/d) being responsible to implement and maintain the commissioning, process validation, qualification of equipment and computerized systems (CQV) in the manufacturing site of Lonza DPS Stein.

Key responsibilities:

Design an E2E DI/CSV Roadmap for the IT infrastructure and pertaining systems for the Growth Facility, ensure proper Quality Systems Design as well as Quality Oversight

Act as Single Point of Contact providing Quality Oversight for all DI/CQV (Life Cycle Management) Projects executed for the Growth Project

Ensure implementation and Quality oversight for the Risk Management Process and periodical reviews pertaining to the DI / CQV Strategy in Line with LEAN Design Principles

Continuously improves the DI Maturity Level of the Dolphin Facility towards Excellence

Review, Assess and Approve all Documents pertaining to CQV Projects and DI 

Establish a robust review mechanism to ensure maintaining the validated status of DI / CSV over given review cycles

Providing guidance, expertise and coaching, assisting sites and their teams for policies, procedures and specifications.

Serve as a Coach / Mentor for Network Key Talents in order to ensure talents development

Key requirements:

Academical degree (Bachelor or higher) in a Life Sciences, Engineering; IT Systems, Industrial Engineering or related science discipline

Strong experience in CSV and Data Integrity within a GMP regulated environment

Significant working experience in a QA role within the pharma industry

Aseptic production experience

Fluency in English, German would be an asset

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: R56985

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