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
Ensure required level of knowledge and skills as well as identify competency gaps and solutions. Lead development and evaluation of new tools, processes, quality initiatives & plans
Be present at the manufacturing line to watch and support with manufacturing-related activities
Support projects and maintain Sterile Production Stein line functions in GMP compliance related issues
Requirements
Degree (BSc, MSc or PhD) in Natural Sciences, Pharmaceutical Sciences or related field
Work experience in sterile drug product manufacturing OR sterile drug substance manufacturing in a GMP controlled environment
Experience in deviation and change management is a prerequisite
Work experience in QA is an advantage
Hands on personality, you openly approach business partners, excellent influencing and negotiation skills
Fluency in English is required, German language skills are an advantage
About Lonza
Ready to shape the future of life sciences?
Benefits
Health insurance
Additional Information
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 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 .
Lonza · Switzerland