Biotech GMP Compliance Lead

MSD Switzerland; Ruswil; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

MSD Switzerland is seeking a Compliance Excellence Specialist (P2) to support GMP compliance and quality systems in biologics manufacturing at Schachen. You will assist investigations, risk assessments, change controls, and continuous improvement activities within assigned areas.

Working with Manufacturing, Quality, Engineering, and MSAT, you will help ensure right-first-time execution, inspection readiness, and compliant documentation while building experience to independently handle broader

Qualifikationen

• Bachelor's or Master's in a scientific/engineering discipline.
• Initial GMP-regulated manufacturing/quality systems experience.
• Understanding of GMP expectations and quality processes.
• Ability to analyze issues using standard procedures with guidance.
• Willingness to further develop expertise.

Aufgaben

• Support GMP deviation records, investigations, and CAPAs.
• Assist root cause analysis and CAPA definition with data gathering.
• Support GMP product-related change controls and risk records.
• Ensure documentation tasks are completed accurately and on time.
• Provide compliance input for production questions and document topics.
• Collaborate across Manufacturing, Quality, Engineering, and MSAT.
• Monitor quality and performance indicators; prepare updates.
• Support inspection readiness and participate in audits.

Kenntnisse

GMP knowledge

Quality processes

Documentation standards

Cross-functional collaboration

German language

English language

Analytical skills

Change management

Regulatory inspection readiness

Ausbildung

Bachelor’s or Master’s in science/engineering

Jobbeschreibung

MSD Switzerland is seeking a Compliance Excellence Specialist (P2) to support GMP compliance and quality systems in biologics manufacturing at Schachen. You will assist investigations, risk assessments, change controls, and continuous improvement activities within assigned areas.

Working with Manufacturing, Quality, Engineering, and MSAT, you will help ensure right-first-time execution, inspection readiness, and compliant documentation while building experience to independently handle broader