QA Senior Specialist, Project Delivery Visp

vor 3 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.

In this role you will be part of Quality Assurance activities for Capex project as part of the Global Quality Engineering team. Projects will be part of in . We are looking for an experienced quality assurance colleagues with drive to ensure the projects are completed on-time with a compliance mindset to add to our high performing team.

Key responsibilities:

Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs

Support the development, review and release of qualification documents according to the Validation Master plan for process plants with specific expertise on documentation for clean utilities

Support and approve quality risk analyses

Release of the qualified process equipment and ensure equipment is assessed with appropriate change management

Ensure all deviations are appropriately investigated and recorded

Responsible to drive CAPA and effectiveness check items to completion and timely closing

Actively supports the Quality culture as a role model

Key requirements:

Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field

Significant experience in the GMP regulated pharmaceutical industry; preferable in a QA role

Strong background in cGMP regulations and expertise in the qualification of Clean Utilities

Experienced in the interaction with health authorities (Swissmedic, FDA etc.)

Excellent verbal, written and interpersonal communication skills in English

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: R58928

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