Quality Assurance Expert Manufacturing Release 80-100%

Vor 6 Tagen


Stein, Schweiz Lonza Vollzeit

Quality Assurance Expert Manufacturing Release 80-100% (f/m/d) 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. Location: Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. What You Will Get: An agile career and a dynamic work culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Additional benefits: https://bit.ly/42DlBDk 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 with internal and external guidelines regarding quality and safety. Ensure required level of knowledge and skills, 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. 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, excellent influencing and negotiation skills. Fluency in English required; German language skills an advantage. About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the 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 are committed to creating an inclusive environment for all employees. Ready to shape the future of life sciences? Apply now. Reference: R72106. #J-18808-Ljbffr


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