Sr. Technical Expert QC

3 maanden geleden

Geleen, Nederland Lonza Voltijd

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.

The Senior Quality Control Expert implements and executes activities in the Quality Control department in the broadest sense while ensuring compliance with all existing GMP and safety standards.

Acting as a contact person in complex issue handling and complex activity performance which requires knowledge and skills in the applicable expertise branch.

As a Senior Technical Expert you will be required to apply scientific skills, current regulatory guidelines and GMP knowledge and experience to provide advice and propose improvements where required.

Key requirements:

M.Sc. / PhD or equivalent in a scientific discipline

10 years of working experience within QC or analytical development

Good knowledge and experience of analytical methods, equipment and good practices for Biological Products.

Good understanding of QC analysis e.g. HPLC, Capillary Electrophoresis, RTPCR, UV Spectrophotometer, Gas chromatography, ELISA, safety tests, BET

Key responsibilities:

Participates in the initial assessment of new methods to be transferred to QC

SME for method specific devices (initiation or review of URS, PQ and define maintenance requirements).

He/she will be responsible for method validation plan including protocol, data review, statistical analysis, report preparation and review

He/she will also lead and participate platform method validation strategy implementation and assessment for future projects.

The technical expert is expected to provide input for problem-solving of issues within his/ hers branch

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: R60356

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