Quality Auditor (Poland)

Qualifyze
Hybrid

About The Position

About Qualifyze: Founded in 2019, 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. Our digital suite of solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts. With a track record of over 4,500 audits across 85+ countries and the largest and most accurate supplier network and data analytics tools, Qualifyze stands as the all-in-one partner for quality compliance and supply chain risk mitigation in the Life Sciences sector.

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.
  • Willingness to travel for on-site audits (domestic and international).

Nice To Haves

  • Czech or German would be a plus.

Responsibilities

  • 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.

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.
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