Senior QA Specialist (m/w/d)

Aristo Group; Neuenburg; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

Aristo Group is seeking a Senior QA Specialist to support GMP operations in the Fill & Finish and Visual Inspection areas. The role involves ensuring compliance with standards, managing deviations, and maintaining documentation. This position is an excellent opportunity for candidates with a strong scientific background and experience in quality assurance within sterile manufacturing.

Qualifikationen

• 2–3 years' QA experience in GMP sterile manufacturing.
• Strong knowledge of production processes and quality systems.
• Proficient in French and English.

Aufgaben

• QA support for new Fill & Finish/Visual Inspection setup.
• Oversight of routine GMP activities in sterile production.
• Review and approval of GMP documents.

Kenntnisse

Quality Assurance

Fill and Finish

Ausbildung

Master’s degree in a scientific field

Jobbeschreibung

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MSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect Match

As a Senior QA Specialist, you will support the implementation of a new Fill & Finish and Visual Inspection area and contribute to routine GMP operations. You'll ensure compliance with cGMP standards, manage deviations, and maintain high-quality documentation.

Type of employment: Payroll

Skills: Quality Assurance,Fill and Finish

Project start: 01.08.2025

Key Responsibilities

• QA support for new Fill & Finish/Visual Inspection setup
• Oversight of routine GMP activities in sterile production
• Review and approval of GMP documents (SOPs, protocols)
• Deviation and CAPA management in TrackWise
• Ensure data integrity and compliance with regulatory standards
• Support audits, batch reviews, GMP tours, and process improvements
• Maintain training compliance and system access rights

Qualifications

• Master’s degree (or equivalent) in a scientific field
• 2–3 years' QA experience in GMP sterile manufacturing
• Strong knowledge of production processes and quality systems
• Proficient in French and English (written and spoken)

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Temporary

Job function

• Job function

  Quality Assurance

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