08 nov
|
Ergomed Group
|
Madrid
08 nov
Ergomed Group
Madrid
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 / Ventajas
- 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 guidelinesResponsabilidades
- 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 experienceRequisitos principales
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📌 Senior Auditor, Quality Assurance (Madrid)
🏢 Ergomed Group
📍 Madrid