GMP Compliance Excellence Specialist

Werthenstein BioPharma GmbH; Schachen; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Werthenstein BioPharma GmbH in Schachen, Lucerne, is seeking a Specialist Compliance Excellence to support GMP compliance and quality systems for biologics manufacturing. The role focuses on deviation investigations, change controls, risk management, and continuous improvement, with collaboration across Manufacturing, Quality, Engineering, and MSAT.

The ideal candidate holds a Bachelor’s or Master’s degree in a scientific field, has GMP exposure, and strong German and English communication

Qualifikationen

• Bachelor’s degree in a scientific discipline; Master’s preferred.
• Initial experience in GMP-regulated manufacturing or quality systems.
• Strong GMP documentation understanding and quality processes.
• Ability to analyze issues and propose solutions with guidance.
• Excellent collaboration across Manufacturing, Quality, Engineering, and MSAT.
• Strong German and English communication skills.

Aufgaben

• Support GMP deviation records, investigations, and CAPAs within scope.
• Assist with change controls, risk records, and risk assessments.
• Provide compliance support for production-related questions and documentation.
• Collaborate with cross-functional teams to align next steps.
• Help ensure inspection readiness and support audits and inspections.
• Monitor quality and performance indicators and contribute to improvements.

Kenntnisse

GMP knowledge

Quality systems experience

German language

English language

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s degree in a scientific/engineering discipline

Jobbeschreibung

Werthenstein BioPharma GmbH in Schachen, Lucerne, is seeking a Specialist Compliance Excellence to support GMP compliance and quality systems for biologics manufacturing. The role focuses on deviation investigations, change controls, risk management, and continuous improvement, with collaboration across Manufacturing, Quality, Engineering, and MSAT.

The ideal candidate holds a Bachelor’s or Master’s degree in a scientific field, has GMP exposure, and strong German and English communication