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Qualifyze

Enhancing healthcare supply chains with data-driven compliance solutions, worldwide.

Quality Auditor

AuditorAuditorFull TimeRemoteSeniorTeam 51-200Since 2019H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

21 hours ago

Salary

zł130K - zł210K / year

Seniority

Senior

Bachelor Degree5 yrs expPolishEnglish

Job Description

Quality Auditor

Qualifyze

• 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.

Job 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.

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