Senior QA Expert (GMP/Sterile) – On-Site with Remote ≤20%

Lonza Group Ltd.; Stein (AR); Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Competitive salary

Lifestyle benefits

Global benefits

Zusammenfassung

Lonza Group Ltd. in Stein (AR), Switzerland, is seeking an experienced QA professional to provide shopfloor oversight for GMP-compliant manufacturing within a dynamic growth project.

You will review GMP documentation, support start-up activities, and partner with manufacturing teams to drive aseptic readiness. The role requires hands-on shopfloor collaboration, strong GMP knowledge, and fluency in German and English.

Qualifikationen

• Proven experience in the pharmaceutical industry within a GMP-regulated environment.
• Experience in quality oversight, management of deviations, CAPAs, and investigations.
• Fluent German and fluent English communication skills.
• Willingness to spend significant time on the manufacturing shopfloor, including full aseptic gowning.
• Bachelor's, Master's or PhD in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology, or related field.

Aufgaben

• Provide QA oversight for shopfloor manufacturing activities within an exciting growth project, ensuring GMP compliance and operational readiness.
• Review and approve SOPs, work instructions, and GMP documentation to support start-up and sustainable operations.
• Partner with Manufacturing teams to drive aseptic process readiness and training support for APS and media fill activities.
• Lead and coordinate quality events by reviewing deviations, CAPAs, investigations, and related quality records.
• Act as the Quality representative during project discussions, audits, and inspections, communicating the quality oversight strategy.

Kenntnisse

QA oversight

GMP

Deviations & CAPAs

SOP review

Aseptic process

German language

English language

Shopfloor familiarity

Ausbildung

Bachelor's/Master's/PhD in Life Sciences or related

Tools

Documentation systems

Jobbeschreibung

Lonza Group Ltd. in Stein (AR), Switzerland, is seeking an experienced QA professional to provide shopfloor oversight for GMP-compliant manufacturing within a dynamic growth project.

You will review GMP documentation, support start-up activities, and partner with manufacturing teams to drive aseptic readiness. The role requires hands-on shopfloor collaboration, strong GMP knowledge, and fluency in German and English.