GMP Quality Auditor — Hybrid, Global Travel & Growth

Qualifyze; España; Hybride; EUR 40 000 - 50 000; Plein temps

Résumé du poste

Qualifyze, a leader in supply chain compliance in Life Sciences, seeks a GMP Auditor to validate audit requests and convert them into scheduled audits. You will conduct 40 remote and on-site audits yearly, ensuring GxP compliance and timely reporting.

The role requires a pharmacy/biotech background, 5+ years GMP auditing experience, and fluency in Spanish and English, with travel domestically and internationally. Hybrid work with global opportunities.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotech, Life Sciences or related field.
• Minimum 5 years of GMP auditing experience in the pharmaceutical industry.
• Evidence of relevant auditor training or justified auditing experience with inspectors.
• Strong knowledge of international GMP regulations and quality systems.
• Excellent organizational, communication, and report-writing skills.
• Professional proficiency in Spanish and English; other languages are a plus.
• Willingness to travel for on-site audits (domestic and international).

Responsabilités

• Prepare GxP audits addressing customer requirements and regulations.
• Conduct 40 remote and on-site audits per year.
• Assess compliance against GxP regulations, guidelines, and procedures.
• Prepare clear, accurate audit reports per internal standards.
• Review audit reports with cross-functional teams for quality.
• Assess CAPA responses to ensure audit findings are addressed.
• Communicate effectively with suppliers, customers, and stakeholders.
• Maintain up-to-date knowledge of applicable GxP regulations.

Connaissances

GxP regulations knowledge

Audit planning

Communication skills

Report writing

Organizational skills

Bilingual Spanish/English

Travel readiness

Formation

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotech, Life Sciences

Description du poste

Qualifyze, a leader in supply chain compliance in Life Sciences, seeks a GMP Auditor to validate audit requests and convert them into scheduled audits. You will conduct 40 remote and on-site audits yearly, ensuring GxP compliance and timely reporting.

The role requires a pharmacy/biotech background, 5+ years GMP auditing experience, and fluency in Spanish and English, with travel domestically and internationally. Hybrid work with global opportunities.