Senior QA Expert – GMP & Aseptic Oversight (Onsite/Remote)

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance rewards

Zusammenfassung

Lonza in Stein, AG, Switzerland seeks an experienced QA professional to provide shopfloor quality oversight for an expanding project. You will ensure GMP compliance, review SOPs, and support aseptic process readiness, contributing to a high-precision manufacturing environment.

The role requires hands-on involvement on the shopfloor, fluency in German and English, and a strong background in life sciences with exposure to regulatory audits. Lonza emphasizes collaboration and high standards.

Qualifikationen

• GMP knowledge and QA oversight required.
• Fluent German and English communication.
• Willingness to work on the shopfloor on aseptic manufacturing.
• Bachelor's/Master's/PhD in Life Sciences or related field.
• Experience with regulatory audits is a plus.

Aufgaben

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

Kenntnisse

GMP knowledge

Quality oversight

German language

English language

Hands-on shopfloor

Ausbildung

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

Jobbeschreibung

Lonza in Stein, AG, Switzerland seeks an experienced QA professional to provide shopfloor quality oversight for an expanding project. You will ensure GMP compliance, review SOPs, and support aseptic process readiness, contributing to a high-precision manufacturing environment.

The role requires hands-on involvement on the shopfloor, fluency in German and English, and a strong background in life sciences with exposure to regulatory audits. Lonza emphasizes collaboration and high standards.