Senior Auditor, Quality Assurance (Pharmacovigilance Audit/GCP Audit experience required)
Ergomed
Ergomed seeks a Senior Auditor for Quality Assurance with expertise in pharmacovigilance and Good Clinical Practice auditing. The role involves conducting internal and client audits, developing audit strategy, managing corrective actions, and providing quality consulting services across pharmaceutical and biotech sectors.
Responsibilities
- Conduct internal and contracted audits for partners, vendors, investigational sites, and third parties
- Lead process and complex audits; review and approve CAPA plans from contracted audits
- Provide quality consulting services including gap analysis, SOP development, and mock inspections
- Serve as main QA contact for designated clients and support regulatory inspections
- Develop audit strategy, train auditors, and maintain knowledge of international regulatory requirements
Requirements
- Bachelor's degree in scientific discipline; Master's degree preferred
- Extensive pharmacovigilance experience with GVP and GCP audit leadership
- Strong analytical, written, and oral communication abilities
- Strategic thinking and risk-based problem-solving capability
- Fluent in English; additional local languages advantageous
- Ability to manage multiple tasks and deliver within timelines
Oferta de empleo publicada 9 días atrás
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