Quality Auditor

Position:
Quality Auditor

Company:
Qualifyze GmbH

Compensation:
€50,000 - €70,000 per year

Location:
Germany, Hessen

Employment type:
Not specified

Work Arrangement:
Remote, Hybrid

Short Summary:
Qualifyze is a leading company in supply chain compliance management in the Life Sciences industry, trusted by over 1,500 pharmaceutical and healthcare companies globally.

Responsibilities:
- 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.

Requirement:
- 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 both Spanish and English. French, Italian, or German 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
- Country specific benefits offering incl. private health care, fitness and meal allowances
- Annual personal development budget to increase your impact
- Hybrid working mode, plus up to 3 months of the year work from anywhere.
- All the best kit and tools to work effectively
- Annual in person all company event and celebration in Europe
- Working with an exceptional team, doing some of the best work of your career