GMP Compliance Excellence Specialist

Merck Gruppe - MSD Sharp & Dohme; Schachen; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Merck Gruppe - MSD Sharp & Dohme in Switzerland (Schachen) seeks a Compliance Excellence Specialist (P2) to support GMP compliance, quality systems, and investigations. You will aid in documentation, CAPAs, change controls, risk records, and continuous improvement while collaborating with Manufacturing, Quality, Engineering, and MSAT to ensure right-first-time execution.

The role emphasizes growing GMP knowledge, timely closure of quality records, and hands-on learning to independently manage

Qualifikationen

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Initial experience in GMP-regulated manufacturing, quality systems, technical operations, or a related area.
• Good understanding of GMP expectations, documentation standards, and quality processes, with willingness to further develop expertise.
• Ability to analyze issues using standard procedures and propose solutions with guidance.
• Strong collaboration skills and ability to work with colleagues across Manufacturing, Quality, Engineering, and MSAT.
• Strong communication skills in German and English.

Aufgaben

• Support GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope.
• Assist root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes.
• Escalate risks, delays, or unclear situations in a timely and structured manner.
• Support GMP product-related change controls and risk records under guidance.
• Contribute to compliant and efficient execution of changes within area of responsibility.
• Provide compliance support for production-related questions, documentation topics, and issue follow-up.

Kenntnisse

Adaptability

Audit readiness

Change management

Data analysis

Documentation

GMP knowledge

Collaboration

German and English

Ausbildung

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

Jobbeschreibung

Merck Gruppe - MSD Sharp & Dohme in Switzerland (Schachen) seeks a Compliance Excellence Specialist (P2) to support GMP compliance, quality systems, and investigations. You will aid in documentation, CAPAs, change controls, risk records, and continuous improvement while collaborating with Manufacturing, Quality, Engineering, and MSAT to ensure right-first-time execution.

The role emphasizes growing GMP knowledge, timely closure of quality records, and hands-on learning to independently manage