Audit & CAPA Lead: Elevate GxP Quality & Readiness

Debiopharm; Lausanne; Hybrid; CHF 100.000 - 130.000; Vollzeit

Benefits dieser Stelle

Inclusive and respectful workplace

Opportunity for collaboration across disciplines

Culture valuing people, purpose, and performance

Zusammenfassung

Debiopharm in Lausanne, Switzerland is looking for an Audit & CAPA Lead to manage an effective audit framework and quality oversight. Responsibilities include strategic audit management, vendor oversight, and leading continuous improvement initiatives across GxP.

Ideal candidates have extensive experience in quality assurance within the pharmaceutical industry and demonstrated ability to conduct GxP audits. This role fosters a collaborative environment that values innovation and growth in healthcare.

Qualifikationen

• 5 to 8 years managing quality assurance in the pharmaceutical/biotech industry.
• Minimum 5 years conducting GxP audits, preferably GCP & GLP.
• 3 years tracking CAPAs, deviations, changes, with electronic quality tools experience.

Aufgaben

• Define and execute the risk-based audit strategy and Master Audit Plan.
• Select and manage auditors for compliance with regulatory standards.
• Develop meaningful metrics for Audit/CAPA oversight.

Kenntnisse

Knowledge of GxP

Experience implementing risk-based approaches

Ability to maintain quality SOPs

Strong organizational and communication skills

Hands-on approach to continuous improvement

Ausbildung

Pharmacist Diploma, PhD, or MSc in Science

Tools

Veeva

Ennov

Jobbeschreibung

Debiopharm in Lausanne, Switzerland is looking for an Audit & CAPA Lead to manage an effective audit framework and quality oversight. Responsibilities include strategic audit management, vendor oversight, and leading continuous improvement initiatives across GxP.

Ideal candidates have extensive experience in quality assurance within the pharmaceutical industry and demonstrated ability to conduct GxP audits. This role fosters a collaborative environment that values innovation and growth in healthcare.