GMP Compliance Excellence Specialist

MSD Malaysia; Schachen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

MSD Malaysia seeks a Compliance Excellence Specialist (P2) to support GMP biologics manufacturing at the Schachen site in Lucerne. You will assist investigations, change controls, risk records, and continuous improvement while ensuring inspection readiness and strong cross‑functional alignment with Manufacturing, Quality, Engineering, and MSAT.

The role emphasizes reliable execution, hands‑on learning, and gradual responsibility building for broader compliance topics over time.

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.

Aufgaben

• Support GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope.
• Assist with root cause analysis and CAPA definition by gathering data and documenting outcomes.
• Provide compliance support for production‑related questions and documentation topics.
• Help monitor quality, compliance, and operational performance indicators and participate in improvement activities.
• Contribute to inspection readiness and support internal and regulatory audits.

Kenntnisse

GMP compliance

Change management

Data analysis

Process improvement

Ausbildung

Bachelor’s or Master’s degree in science/engineering

Jobbeschreibung

MSD Malaysia seeks a Compliance Excellence Specialist (P2) to support GMP biologics manufacturing at the Schachen site in Lucerne. You will assist investigations, change controls, risk records, and continuous improvement while ensuring inspection readiness and strong cross‑functional alignment with Manufacturing, Quality, Engineering, and MSAT.

The role emphasizes reliable execution, hands‑on learning, and gradual responsibility building for broader compliance topics over time.