Quality Assurance Expert Manufacturing Release 80-100% (f/m/d)

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!

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.

• Benefits in Stein: 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 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 

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

• 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

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. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. 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.