Stability & Raw Materials QC Lead (GMP)

Incyte Corporation; Schweiz; Hybrid; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Incyte Corporation in Switzerland seeks a QC Specialist for Stability and Raw Materials at the BioPlant QC team. You will plan RM lab activities, drive stability studies, and coordinate testing with QC analysts, QA, and external labs to ensure timely results.

The role requires GMP experience in pharma/biotech, deep knowledge of analytical testing and pharmacopoeias, and fluency in French with advanced English.

Qualifikationen

• Bachelor with 5 years or CFC/BTS with at least 10 years in a laboratory environment.
• Strong GMP experience in a pharmaceutical or biotechnology setting.
• Deep knowledge of analytical testing and pharmacopoeias.
• Able to operate in a highly regulated, fast-changing environment.
• Fluent French and advanced English (C1).

Aufgaben

• Plan and coordinate RM lab activities for the team of technicians.
• Coordinate stability studies per ICH and regulatory requirements.
• Ensure timely completion of testing with QC analysts and supervisors.
• Act as primary contact for stability-related queries across QA, Manufacturing, Regulatory, and Supply Chain.
• Support regulatory submissions with stability data and summaries.
• Lead deviations, CAPA, and change controls for QC activities.
• Author and maintain SOPs, work instructions, and quality documents.

Kenntnisse

GMP experience

Analytical testing

Pharmacopoeias

Regulatory environment

Team spirit

Proactivity

Rigorous

Synthesis

French (fluent)

English (advanced)

Ausbildung

Bachelor with 5 years

CFC / BTS in Physico-chemistry or Biotechnology

Jobbeschreibung

Incyte Corporation in Switzerland seeks a QC Specialist for Stability and Raw Materials at the BioPlant QC team. You will plan RM lab activities, drive stability studies, and coordinate testing with QC analysts, QA, and external labs to ensure timely results.

The role requires GMP experience in pharma/biotech, deep knowledge of analytical testing and pharmacopoeias, and fluency in French with advanced English.