Jobdescription
Are you the person who actually enjoys the adrenaline of a surprise inspection? Do you find the "missing link" in a paper trail before anyone else even realizes it's gone?
Our client, a Randstad client, is looking for a Senior QMS & Compliance Expert to join their team in Visp. We need someone who treats Auditing as an art form, Compliance as a religion, and the Quality Management System (QMS) as their personal masterpiece.
If you can stare down a regulatory inspector with a calm smile and a perfectly organized folder of evidence, we want to talk to you.
Your Main Acts
1. The Audit Maestro (Your Top Priority)
You aren't just attending inspections; you're conducting the orchestra.
* The Front Line: Act as the primary QA lead for health authority inspections (FDA, Swissmedic) and customer audits. You're the face of the site when the stakes are high.
* The Follow-Through: Own the CAPA lifecycle from birth to burial. You'll ensure observations aren't just "fixed" but solved for good.
* Self-Correction: Lead internal self-inspections to ensure we catch our own hiccups long before an inspector pulls into the parking lot.
2. The QMS Architect & Compliance Guru
You'll be the proud owner of the Quality Management System, ensuring it's not just a collection of binders, but a living, breathing engine of excellence.
* System Ownership: Take the wheel on Deviations, Change Control, Document Management, and Training.
* Risk Mastery: Lead Quality Risk Management (QRM) in line with ICH Q9. You'll maintain the Risk Register like a sacred text, ensuring every threat is documented, mitigated, and escalated.
* SOP Artistry: Author and approve SOPs that are actually readable, compliant with GMP, and bulletproof under scrutiny.
Your Backstory
* The Veteran: You have 8–10 years in the GMP trenches (Pharma/Biotech). If you have experience in sterile manufacturing, you're already our favorite.
* The Inspector Whisperer: You've gone toe-to-toe with the FDA and Swissmedic and lived to tell the tale. You know exactly what they're looking for before they even ask.
* The Regulatory Librarian: You know EU GMP, FDA, ICH, and Annex 1 guidelines better than your own Netflix password.
* The Calm in the Storm: You are structured, resilient, and possess the "grace under fire" required when an audit gets intense.
* The Linguist: You are fluent in English. If you can navigate a conversation in German, that's a major bonus.
Why join this Randstad client?
They are a high-growth CDMO where Quality isn't a department—it's the backbone of their reputation. You won't just be checking boxes; you'll be building the gold standard of compliance.
Ready to own the audit? Let's talk.