🤝Assignment via GXP Consulting Switzerland — specialist pharma/biotech consulting firm. Full administrative support included.
A global pharmaceutical leader is transforming its Schaffhausen site through a 650M€+ 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.
* 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; escape and resolve issues immediately
* Coach and support operators and line managers in adherence to SOPs and good manufacturing practices
* CAPA managementInvestigate shopfloor deviations, drive corrective and preventive actions (
* Participate in quality reviews, walkthroughs, internal and regulatory inspections
* EU Annex 1 compliance programme in production zonesContribute actively to the
* Work closely with Production, QA and Engineering teams across a complex multi-project environment
Required:
* Scientific degree — pharmacy, chemistry, biology or engineering
* GMP pharma or biotech environment5+ years of hands-on experience in shopfloor quality or compliance within a
* EU Annex 1, FDA 21 CFR, cGMP frameworksStrong practical knowledge of
* 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
* B2 minimum — mandatory for this positionFluent German (
* Professional English
Strong assets:
* Autonomous, rigorous, with strong interpersonal and coaching skills
* Experience with regulatory inspections (FDA, Swissmedic, EMA)
💡 What's Offered
* 650M€+ investment programme — a rare opportunity at this scaleIntegration into a landmark
* 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 through GXP Consulting Switzerland, with strong extension potential
* International environment, cross-functional teams, global standards
* Confidential process — guaranteed response within 48 hours
GMP EU Annex 1 FDA 21 CFR cGMP CAPA Deviation Management Change Control Shopfloor Compliance QMS Audit
Production Quality Pharma Biotech Swissmedic GXP Consulting Schaffhausen Greenfield Clinical Manufacturing Freelance
Confidential recruitment managed by Recrutis on behalf of GXP Consulting Switzerland.
Your application will be handled with full discretion. Guaranteed response within 48 hours.
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