GMP Compliance Specialist – CAPA & Change Control

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Incyte in Switzerland (Waadt region) seeks a Compliance Specialist to oversee cGMP manufacturing quality topics, including deviation management, CAPA, risk management, change control, training, and batch record review.

The role includes acting as SME during authorities inspections, developing KPI dashboards, authoring SOPs, mentoring DSP teams, and driving continuous improvement with QA. Fluent in French and English; requires a pharma/biotech degree and 3–5 years in a regulated biotech setting.

Qualifikationen

• Degree in pharma/biotech engineering or equivalent required.
• Direct experience in cGMP drug manufacturing and quality.
• Strong experience with FMEA and root cause analysis.
• Proficiency in quality assurance tools and methods.
• Fluent in French and English; good collaboration skills.
• Experience in fast-paced regulated manufacturing environments.

Aufgaben

• Ensure systems are ready for inspection at all times.
• Raise, investigate, assess and close deviations within timelines.
• Define and plan CAPA to avoid recurrence and improve processes.
• Define and plan effectiveness checks.
• Manage Change Controls to resolve compliance and drive improvements.
• Define and maintain KPIs for manufacturing quality and performance.
• Act as SME during health authorities inspections; present risks, deviations, investigations, CCPs and CAPAs.
• Develop and maintain business KPIs and support continuous improvement.
• Author, review and approve SOPs and manufacturing documents.
• Mentor DSP manufacturing team; enforce GMP practices.
• Coach and train manufacturing staff to GMP guidelines and SOPs.
• Provide cross-department training on quality concepts.
• Proactively propose problem resolution for processes and equipment.
• Review and support execution of batch records (exception reviews).
• Implement quality compliance initiatives with QA support.
• Coach and support team members on quality matters.
• Promote a culture of integrity and compliance with company policies.
• Delegate to DSP Manager / Process Support Manager.

Kenntnisse

cGMP experience

FMEA

Root cause analysis

Quality assessment tools

French and English fluency

Teamwork

Compliance mindset

Ausbildung

BSc/Master/Engineering in Pharma/Biotech

Jobbeschreibung

Incyte in Switzerland (Waadt region) seeks a Compliance Specialist to oversee cGMP manufacturing quality topics, including deviation management, CAPA, risk management, change control, training, and batch record review.

The role includes acting as SME during authorities inspections, developing KPI dashboards, authoring SOPs, mentoring DSP teams, and driving continuous improvement with QA. Fluent in French and English; requires a pharma/biotech degree and 3–5 years in a regulated biotech setting.