GMP Compliance Engineer

About

You will support GMP compliance activities within a regulated production environment with strong exposure to audits and quality systems.

Senior role, on-site, immediate start.

Key Information

• Location: Switzerland (on-site)
• Contract: Long-term consulting assignment
• Start date: ASAP
• Seniority: 5+ years experience required
• Languages: English required, German is a strong plus

Your Role

You will ensure GMP compliance across aseptic manufacturing operations, supporting quality systems, audits and continuous improvement.

Key Responsibilities

• Manage deviations, CAPAs and change controls
• Ensure compliance with GMP standards (EU Annex 1, FDA)
• Support regulatory inspections (FDA, EMA, Swissmedic)
• Review and update GMP documentation (SOPs, protocols)
• Work closely with Production, QA and Engineering teams
• Contribute to continuous improvement of quality systems

Your Profile

• 5+ years experience in GMP Compliance in pharma or biotech
• Strong exposure to aseptic manufacturing environments
• Solid knowledge of EU GMP (Annex 1 highly preferred)
• Experience supporting audits and inspections
• Structured, detail-oriented and autonomous
• German C1 mandatory

Why This Role

• High-exposure GMP environment
• Strong regulatory and audit dimension
• Strategic role within operations
• Long-term project visibility

Process

Confidential process with response within 48 hours.

Immediate need – priority review of relevant applications.