Experteer Overview In this role you will manage and execute internal and contracted audits within a GxP framework, shaping audit strategy and leading complex audits.
You will provide QA consultancy and serve as the main QA contact for designated clients, supporting Quality as a Service activities and training.
You will help evolve the internal audit program while keeping up-to-date with regulatory requirements, ensuring timely CAPA delivery and robust audit governance.
This position offers impact across client and company audits, with opportunities to influence quality processes and strategic direction.
Compensaciones / Incentivos
• Conduct and manage audits initiated by the company or contracted for clients within the Audit Program, including pre-audit activities
• Perform diverse audit types (internal, vendor/partner, study, third-party) under GxP
• Review and approve CAPA plans within required timelines
• Provide QA consultancy (PV/QMS gap analysis, SOP development)
• Act as main QA contact for designated clients and report audit findings
• Participate in Quality as a Service activities (mock inspections, training, gap analysis, procedure drafting)
• Support audits and inspections conducted by clients and regulators
• Collaborate with Quality leadership to train auditors and develop the internal audit program
• Maintain up-to-date regulatory knowledge and contribute to knowledge sharing
• Assist in authoring or QC of audit strategy, SOPs, and guidelines Responsabilidades
• GxP auditing experience
• Ability to conduct and lead audits for various scopes (internal, vendor, third-party)
• Experience with CAPA review and closure
• Client-facing QA experience
• Knowledge of regulatory requirements and best practices in quality systems
• Capability to develop SOPs and provide consultancy
• Team leadership or mentorship experience Requisitos principales •
📌 Senior Auditor, Quality Assurance (Madrid)
🏢 Ergomed Group
📍 Madrid
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