Overview
(Senior) GMP/GDP QA Auditor (m/f/d) Jobs in Basel-Country, Switzerland at Skilled Recruitment Solutions GmbH
Title: (Senior) GMP/GDP QA Auditor (m/f/d)
Company: Skilled Recruitment Solutions GmbH
Location: Basel-Country, Switzerland
Ihre Aufgaben
- Spearhead the creation and execution of the annual external QA audit and internal self-inspection plans
- Conduct thorough GMP/GDP audits and self-inspections in close coordination with internal departments and global suppliers
- Promptly report and escalate critical audit findings to the Responsible Person (RP) and senior management
- Create, negotiate, and maintain Quality Agreements (QAs) with external suppliers and vendors
- Act as the primary bridge between Quality, Regulatory Affairs, Compliance, and Operations
- Manage and oversee Change Controls, Deviations, and CAPAs (Corrective and Preventive Actions) related to audit findings
- Support the site and the QA team in preparing for upcoming health authority and regulatory inspections
Ihr Profil
- Minimum of 3–6 years of auditing experience within a strict GMP/GDP regulated environment, including at least 1 year acting as a Lead Auditor
- Deep and excellent knowledge of international GMP/GDP guidelines, quality regulations, and industry best practices
- Proven ability to manage complex quality projects independently and drive them to successful completion
- High level of detail-orientation, strong analytical skills, and a diplomatic yet assertive communication style
- Fluency in English (written and spoken) is mandatory. Basic knowledge of another European language is a strong asset
