GMP Compliance Specialist — CAPA & Deviation (DSP)

Incyte; Yverdon-les-Bains; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Incyte in Switzerland seeks a Compliance Specialist to manage deviation, CAPA and risk management. You will support cGMP and site quality goals in manufacturing, lead continuous improvement projects and review manufacturing documents to ensure compliance.

The role requires 3–5 years in biotech quality with strong analytical skills, and fluency in English and French. You will mentor the DSP manufacturing team and ensure adherence to GMP guidelines.

Qualifikationen

• 3–5 years in biotech with cGMP drug manufacturing and quality responsibility.
• Experience with deviation management, CAPA and investigations.
• FMEA, root cause analysis and related quality tools are required.

Aufgaben

• Ensure systems are inspection-ready at all times.
• Raise, investigate, assess and close deviations within timelines.
• Define and plan CAPA for recurrence prevention and process improvement.
• Define and plan effectiveness checks for improvements.
• Manage Change Controls and ensure regulatory compliance.
• Develop KPI for manufacturing quality and operations performance.
• Act as SME during health authorities inspections and present CAPAs.
• Coach and train staff on GMP guidelines and SOPs.

Kenntnisse

FMEA

Root Cause Analysis

Quality Assessment Tools

Training & SOP Review

Team Collaboration

Biotech cGMP knowledge

English & French proficiency

Ausbildung

BSc/Master/Engineering in Pharma/Biotech

Jobbeschreibung

Incyte in Switzerland seeks a Compliance Specialist to manage deviation, CAPA and risk management. You will support cGMP and site quality goals in manufacturing, lead continuous improvement projects and review manufacturing documents to ensure compliance.

The role requires 3–5 years in biotech quality with strong analytical skills, and fluency in English and French. You will mentor the DSP manufacturing team and ensure adherence to GMP guidelines.