[Hiring] Quality Auditor @Qualifyze GmbH

Role Description

As a Quality Auditor, you will play a key role in ensuring pharmaceutical suppliers meet the highest standards of quality and regulatory compliance. Working within the Quality team, you will independently manage and conduct audits across an international supplier network, collaborating closely with customers, suppliers, and internal stakeholders to drive quality and continuous improvement.

• Prepare GxP audits, ensuring customer requirements and applicable regulations are adequately addressed.
• Conduct 40 remote and on-site audits of pharmaceutical providers per year.
• Assess compliance against applicable GxP regulations, guidelines, and internal procedures.
• Prepare clear, accurate, and timely audit reports in accordance with internal quality standards.
• Participate in the audit report review process, collaborating with cross-functional teams to ensure consistency and quality.
• Review and assess supplier CAPA responses to ensure audit findings are appropriately addressed.
• Communicate effectively with suppliers, customers, and internal stakeholders throughout the audit lifecycle.
• Maintain up-to-date knowledge of applicable GxP regulations and industry best practices.
• Support continuous improvement initiatives related to auditing methodologies, procedures, and quality processes.

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 and accredited auditor training or justified experience in auditing with experienced inspectors.
• Strong knowledge of international GMP regulations and quality systems.
• Excellent organizational, communication, and report-writing skills.
• Professional proficiency in English and one of the following languages: Polish, Czech, German, Hungarian, Romanian, Bulgarian, Slovakian, or Serbian. Any additional languages would be a plus.
• Willingness to travel for on-site audits (domestic and international).

Requirements

• Minimum 5 years of GMP auditing experience in the pharmaceutical industry.
• Evidence of relevant and accredited auditor training or justified experience in auditing with experienced inspectors.
• Strong knowledge of international GMP regulations and quality systems.
• Excellent organizational, communication, and report-writing skills.
• Professional proficiency in English and one of the following languages: Polish, Czech, German, Hungarian, Romanian, Bulgarian, Slovakian, or Serbian. Any additional languages would be a plus.
• Willingness to travel for on-site audits (domestic and international).

Benefits

• Competitive, annually reviewed compensation package.
• Country vacation package that increases with your tenure.
• Flexible schedules throughout the year.
• The option to work from abroad for up to 45 days per year.
• All necessary work equipment (laptop, headphones, etc.).
• Two official company events per year to celebrate success.
• Individual coaching and mentoring on your development roadmap within Qualifyze.
• Working with an exceptional team, doing some of the best work of your career.