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Senior QA Specialist

vor 2 Monaten


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 Visp we are looking for a QA Specialist who will support to establish and maintain quality management & compliance processes at Visp site. The QA Specialist will be responsible to provide QA support in the Bioconjugates Business Unit. You will work closely with various quality and operational functions to ensure GMP-compliant manufacturing and documentation.

Key responsibilities:

Coordinate QA interests during the different project phases

Responsible for project specific QA Operation tasks during commissioning/qualification

Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc

Support the contract manufacturing and advise members of development, production and analytical departments on all aspects of GMP

Experience in a customer focused environment, managing independently stakeholders and their needs

Participate and support regulatory inspections and customer audits

Key requirements:

Bachelor's or Master’s degree in Biotechnology, Biochemistry, or a related field

Significant experience in the area of biopharmaceutical manufacturing, preferably in a QA function

Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk management

Sound experience in representing Quality and Compliance in projects

Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)

Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAP

Excellent written and spoken English - knowledge of written and spoken German would be 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.

Reference: R61019