Quality Auditor

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Qualifyze

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

📋 Compliance

💊 Pharmaceuticals

☁️ SaaS

Compliance • Pharmaceuticals • SaaS

Qualifyze is a company providing an end-to-end audit management platform and the world's largest quality audit library. Specializing in global supply chain transparency and collaboration, Qualifyze offers a comprehensive supplier directory and intelligence solutions, serving as a hub for audit planning and regulatory compliance. With over 250 global audit professionals, the company delivers swift reports and supplier risk management insights, leveraging a vast compliance data set. Qualifyze is committed to enhancing supplier reliability and ensuring compliance with various international standards, catering to industries like pharmaceuticals.

📋 Description

• Prepare GxP audits, ensuring customer requirements and applicable regulations are adequately addressed. • Conduct remote and on-site audits of pharmaceutical providers. • 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.

🎯 Requirements

• 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 Polish and English. • Czech 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. • 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.