À propos du poste GMP Compliance Specialist – Production / Pharma
Région Zurich, Switzerland On-site Long-term Contract Senior level (5+ years) German B2 required English professional
Assignment via a specialist pharma/biotech consulting firm. Full administrative support included.
Context A global pharmaceutical leader is transforming its site in the Zurich region through a major investment programme — including EU Annex 1 compliance, a greenfield facility, and new clinical batch production capacities.
As part of this transformation, the site is strengthening its shopfloor Compliance team. This is not a desk-based quality role — it is a hands-on position embedded directly within production, working alongside operators and line managers to drive real-time GMP compliance.
If you thrive on the production floor, know GMP inside out, and can coach as well as challenge — this role was built for you.
Key Responsibilities
- Provide on-the-floor quality presence within production areas — your office is the shopfloor
- Verify GMP compliance of practices in real time on production lines; escalate and resolve issues immediately
- Coach and support operators and line managers in adherence to SOPs and good manufacturing practices
- Investigate shopfloor deviations, drive corrective and preventive actions (CAPA management)
- Participate in quality reviews, walkthroughs, internal and regulatory inspections
- Contribute actively to the EU Annex 1 compliance programme in production zones
- Work closely with Production, QA and Engineering teams across a complex multi-project environment
Your Profile Required:
- Scientific degree — pharmacy, chemistry, biology or engineering
- 5+ years of hands-on experience in shopfloor quality or compliance within a GMP pharma or biotech environment
- Strong practical knowledge of EU Annex 1, FDA 21 CFR, cGMP frameworks
- Proven experience with deviation management, CAPA, change control — on the ground, not just on paper
- Hands-on profile: genuinely comfortable working directly in production areas
- Fluent German (B2 minimum — mandatory for this position)
- Professional English
Strong assets:
- Autonomous, rigorous, with strong interpersonal and coaching skills
- Experience with regulatory inspections (FDA, Swissmedic, EMA)
What's Offered
- Landmark-scale site transformation programme — rare scope and long-term visibility
- Key role at the heart of production — direct impact on quality, compliance and patient safety
- Strategic projects: EU Annex 1 upgrade, greenfield build, clinical batch scale-up
- Long-term contract with strong extension potential
- International environment, cross-functional teams, global standards
- Confidential process — guaranteed response within 48 hours
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