Location
Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
About the Role
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. This role is fully site‑based, supporting close real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. The position is part‑time at 60%.
What You Will Get
* Agile career and a dynamic work culture.
* Inclusive and ethical workplace.
* Compensation programs that recognize high performance.
* Competitive salary and numerous lifestyle, family and leisure benefits.
* Full list of our global 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 databases (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 knowledge and skills, identify competency gaps, and develop solutions. Lead development and evaluation of new tools, processes, quality initiatives and plans.
* Be present at the manufacturing line to observe and support manufacturing‑related activities.
* Support projects and maintain Sterile Production Stein line functions in GMP compliance related issues.
What We Are Looking For
* 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.
* Experience in QA is an advantage.
* Hands‑on personality, open approach to business partners, excellent influencing and negotiation skills.
* Fluency in English required, German language skills advantage.
About Lonza
At Lonza, our people are our greatest strength. With over 30 sites across five continents, our globally connected teams manufacture medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. We value diversity and create inclusive environments. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Reference: R76523
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