GMP QA Associate - Inspections & Global Stakeholders

Real; Bezirk Solothurn; Vor Ort; CHF 60.000 - 90.000; Teilzeit

Zusammenfassung

Real in Solothurn, Switzerland seeks a Quality Assurance Associate to support GMP-regulated operations in a biopharmaceutical setting. The role focuses on quality compliance, onboarding, and coordination across global stakeholders, at 80% workload.

You will help maintain the site QMS, assist with inspections and CAPA management, and ensure documentation reviews meet regulatory standards. This position is ideal for a junior quality professional looking to grow in a highly regulated manufacturing

Qualifikationen

• Must have GMP knowledge and practical experience in GMP-regulated environments.
• Solid understanding of Quality Management Systems and quality processes.
• Experience with CAPA management, deviations, and change controls.
• Excellent communication with global stakeholders.

Aufgaben

• Maintain and continuously improve the site QMS.
• Support GMP compliance activities and inspection readiness.
• Assist onboarding for employees, suppliers, and contractors.
• Coordinate quality governance meetings and track actions.
• Manage deviations, CAPAs, and change controls.
• Review quality documentation for compliance.
• Prepare quality metrics, reports, and KPI data.
• Support internal audits and inspections.
• Liaise with cross-functional teams across locations.
• Keep accurate records in electronic QMS.

Kenntnisse

GMP knowledge

Quality mindset

Strong organizational skills

Cross-functional communication

Fluent English

Ausbildung

Bachelor's degree in Life Sciences/Pharma

Quality Management certification

Tools

TrackWise

Oracle PLM

QMS software

Jobbeschreibung

Real in Solothurn, Switzerland seeks a Quality Assurance Associate to support GMP-regulated operations in a biopharmaceutical setting. The role focuses on quality compliance, onboarding, and coordination across global stakeholders, at 80% workload.

You will help maintain the site QMS, assist with inspections and CAPA management, and ensure documentation reviews meet regulatory standards. This position is ideal for a junior quality professional looking to grow in a highly regulated manufacturing