GMP Compliance Excellence Specialist

MSD Malaysia; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in Lucerne (Schachen) is seeking a Specialist Compliance Excellence (m/f/d) to support GMP compliance and quality systems for biologics manufacturing.

You will work with Manufacturing, Quality, Engineering, and MSAT to help ensure right-first-time execution, inspection readiness, and timely documentation. The role emphasizes investigations, CAPAs, change controls, risk records, and continuous improvement under guidance, with opportunities to grow into broader compliance topics.

Qualifikationen

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Initial experience in GMP-regulated manufacturing, quality systems, or related area.
• Good understanding of GMP expectations, documentation standards, and quality processes.

Aufgaben

• Support GMP deviation records, investigations, impact assessments, and CAPAs.
• Assist GMP change controls and risk records under guidance.
• Provide compliance support for production-related questions and documentation topics.
• Collaborate with Manufacturing, Quality, Engineering, and MSAT to align next steps.
• Assist in inspection readiness activities and audits.

Kenntnisse

Adaptability

Audit Processes

Audit Readiness

Change Management

Data Analysis

Quality Documentation

GMP Knowledge

Ausbildung

Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline

Jobbeschreibung

Merck & Co., Inc. in Lucerne (Schachen) is seeking a Specialist Compliance Excellence (m/f/d) to support GMP compliance and quality systems for biologics manufacturing.

You will work with Manufacturing, Quality, Engineering, and MSAT to help ensure right-first-time execution, inspection readiness, and timely documentation. The role emphasizes investigations, CAPAs, change controls, risk records, and continuous improvement under guidance, with opportunities to grow into broader compliance topics.