GxP Compliance & QA Specialist — Validation & Audits

Novartis; Stein; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Novartis seeks a qualified professional to provide specialist support for the Quality Management System, ensuring site and product activities comply with cGxP, data integrity, and internal standards. You will coordinate CAPA, assist with audits, validation, and change controls, and oversee DI/eCompliance training to maintain high quality and regulatory readiness.

The role emphasizes collaboration, continuous learning, and strong proficiency with GMP knowledge and MS Office tools to streamline

Qualifikationen

• University degree with a scientific/technological background.
• Good written and spoken English; fluent in local language.
• Experience in pharmaceutical quality control, quality assurance or production.

Aufgaben

• Ensure activities comply with cGxP and data integrity.
• Support site qualification and validation planning, advising and review.
• Documentation management and archiving.
• Coordinate CAPA activities and follow-up.
• Audit and inspection preparation and support.
• Review/approve routine change controls.
• Oversee local DI and eCompliance training and risk IDs.
• Support process quality assurance per regulations.
• Track KPI trends and report results.

Kenntnisse

Collaboration

Operational Excellence

Digital & Tech Savvy

Resilience

MS Office

Quality Assurance

GMP Knowledge

Ausbildung

University degree in Chemistry/Pharmacy/Biology/Biochemistry

Scientific/technological background

Jobbeschreibung

Novartis seeks a qualified professional to provide specialist support for the Quality Management System, ensuring site and product activities comply with cGxP, data integrity, and internal standards. You will coordinate CAPA, assist with audits, validation, and change controls, and oversee DI/eCompliance training to maintain high quality and regulatory readiness.

The role emphasizes collaboration, continuous learning, and strong proficiency with GMP knowledge and MS Office tools to streamline