Quality Assurance Specialist — GMP & Compliance

Zvh; San Vittore; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Baxter is seeking a Quality Assurance Specialist to ensure plant activities comply with GMP and quality policies, leading investigations and driving corrective actions across cross-functional teams.

You will support supplier qualification, audits, and training, while maintaining electronic quality documentation and ensuring readiness for inspections. Strong collaboration and a proactive approach are essential in this role.

Qualifikationen

• Experience with Quality Management Systems (QMS) and GMP/ISO 13485.
• Proven ability to lead investigations and corrective actions.
• Strong safety awareness and adherence to internal procedures.
• Excellent communication and cross-team collaboration.

Aufgaben

• Be responsible for quality records creation, review, distribution and archiving per Good Documentation Practices.
• Lead non-conformity investigations and CAPA plans, identify root causes and implement sustainable solutions.
• Drive supplier qualification and supplier quality activities to meet Baxter standards.
• Support internal and external audits and readiness for inspections.
• Provide training and coaching across areas to maintain high compliance standards.
• Review and update quality policies, procedures and Quality Manual to align with requirements.
• Manage electronic quality documentation to keep records accurate and accessible.
• Partner with departments to keep processes current and effective.
• Promote a culture of continuous improvement and process efficiency.

Kenntnisse

QMS & GMP

ISO 13485

CAPA investigations

Investigations management

Cross-functional collaboration

English & Italian

Ausbildung

Engineering or Scientific degree

Jobbeschreibung

Baxter is seeking a Quality Assurance Specialist to ensure plant activities comply with GMP and quality policies, leading investigations and driving corrective actions across cross-functional teams.

You will support supplier qualification, audits, and training, while maintaining electronic quality documentation and ensuring readiness for inspections. Strong collaboration and a proactive approach are essential in this role.