Lonza
Manufacturing
QAExpert,ManufacturingRelease
Neural analysis suggests this role is
optimal for Mid candidates.
“QA Expert, Manufacturing Release at Lonza. Skills: Batch release, GMP compliance, Deviation management. Perform batch release for aseptic manufactured drug product. Write, review and approve deliverables”
What You'll Achieve.
Ensuring product quality requirements are met; Providing rigorous oversight
Industry & Context.
What They're Looking For.
Must Have
Work experience in sterile drug product manufacturing OR sterile drug substance manufacturing in a GMP controlled environment, Experience in deviation and change management
Nice to Have
Work experience in QA
What You'll Do.
Perform batch release for aseptic manufactured drug product
review and approve deliverables
Review and approve documents
Approve change requests
Promote and enforce compliance to guidelines
Ensure required level of knowledge and skills
Lead development and evaluation of new tools
Be present at the manufacturing line
Support projects and maintain Sterile Production Stein line functions
How You'll Work.
Team & Collaboration
Work together in person supports close, real-time collaboration
Full Job Description
The location of this job is in **Stein, AG, Switzerland**. Relocation assistance is available for eligible candidates and their families, if needed. Join our [Drug Product Services](https://www.youtube.com/watch?v=gEXvtbcdNdA&list=PLh3u2rKfWyIfXC2d2O3enUrpMjjJ7DO_x&index=4) team in Stein, Switzerland – a leading CDMO branch shaping the future of patient treatment. As a Quality Assurance Expert Manufacturing Release, you’ll play a key role in the release of drug product from our aseptic fill&finish lines, ensuring product quality requirements are met while providing rigorous oversight from technical transfer, manufacturing and release. Be part of a team that drives excellence and innovation in global healthcare! This is an ideal opportunity for people who wish to work **parttime 60%**. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. **What you will get:** * An agile career and a dynamic work culture. * An inclusive and ethical workplace. * Compensation programs that recognize high performance. In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below. * The full list of our global benefits can be found here: **[ _https://www.lonza.com/careers/benefits_](https://www.lonza.com/careers/benefits).** **What you will do:** * Perform batch release for aseptic manufactured drug product * Write, review and approve deliverables (e.g. procedures, SOPs, risk assessments, gap assessments) and related data bases (e.g. training, validation) to ensure GMP compliance * Review and approve documents in both electronic systems (e.g. MES) and paper-based. Approve change requests, deviation and CAPAs related to product and process * Promote and enforce compliance to internal and external guidelines regarding quality and safety * Ens
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