Senior QA Specialist, Plant Qualification 80-100% (m/f/d)

Job title:

Senior QA Specialist, Plant Qualification 80-100% (m/f/d)

Company

Lonza

Job description

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 our site in Visp we are looking for a (Senior) QA Specialist, Qualification (f/m/d), who will support our team QA plant qualification.Key responsibilities:Representative of QA Qualification in the project organization for new facilities or other projects in regard to qualification of facilities, utilities, equipment and systemsCoordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectivesDriving implementation of new qualification strategy and being a strong decision maker when neededCompiling, reviewing and releasing Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports and more) as also supporting and approving quality risk analysis (e.g. FMEA)Performing assessments and approvals of technical change requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systemsRepresenting qualification topics during customer audits and regulatory inspectionsBeing responsible to drive CAPA and Effectiveness Checks to completion and timely closing as well ensuring deviations are appropriately investigated and recorded in Deviation ReportsKey requirements:University degree in Engineering / Chemistry / Biotechnology or any related fieldSignificant experience in the pharmaceutical industry, ideally in a QA roleGood understanding of the applicable cGMP regulations would be an advantageGeneral knowledge of engineering and manufacturing processesAbility to oversee project execution to identify non-compliance from quality standardsFluent language skills in German and English requiredEvery 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.

Expected salary

Location

Suisse

Job date

Fri, 28 Feb 2025 08:18:41 GMT

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