Senior GMP/GDP QA Auditor; m/f/d
Listed on 2026-07-12
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Quality Assurance - QA/QC
Data Analyst, Regulatory Compliance Specialist
Contract Type: 12-Month Contract (with a strong option for permanent internal takeover)
Industry: Pharmaceutical / Biotechnology
About the RoleWe are seeking a dynamic and highly motivated (Senior) GMP/GDP QA Auditor to join a dedicated quality assurance team in Region Basel. In this pivotal role, you will take full ownership of the audit life cycle, ensuring the highest standards of compliance across both internal operations and external supplier networks. This position offers a fantastic blend of strategic planning and hands‑on execution, with a very clear pathway to transition into a permanent role.
Key Responsibilities- Audit Planning & Ownership
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Spearhead the creation and execution of the annual external QA audit and internal self-inspection plans - Execution
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Conduct thorough GMP/GDP audits and self-inspections in close coordination with internal departments and global suppliers - Risk Management
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Promptly report and raise critical audit findings to the Responsible Person (RP) and senior management - Supplier Quality
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Create, negotiate, and maintain Quality Agreements (QAs) with external suppliers and vendors - Cross-Functional Interface
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Act as the primary bridge between Quality, Regulatory Affairs, Compliance, and Operations - Quality Systems
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Manage and oversee Change Controls, Deviations, and CAPAs (Corrective and Preventive Actions) related to audit findings - Inspection Readiness
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Support the site and the QA team in preparing for upcoming health authority and regulatory inspections
- Experience
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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 - Expertise
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Deep and excellent knowledge of international GMP/GDP guidelines, quality regulations, and industry best practices - Project Management
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Proven ability to manage complex quality projects independently and drive them to successful completion - Mindset
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High level of detail-orientation, strong analytical skills, and a diplomatic yet assertive communication style - Languages:
Fluency in English (written and spoken) is mandatory
. Basic knowledge of another European language is a strong asset
Interested in this opportunity
? If this position has sparked your interest,
apply today
! Send us your CV and take the next step in your career with an exciting opportunity in the pharmaceutical industry.
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