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Pharmaceutical Quality Auditor

2 tygodni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Quality Assurance Auditor

We are seeking a detail-oriented Quality Assurance Auditor to join our team in Warsaw, Poland. As a key member of our Quality Assurance team, you will be responsible for conducting independent clinical audits to assess compliance with regulations, guidelines, and operating procedures.

Key Responsibilities:

  • Plan, schedule, conduct, report, and close audit activities to assess compliance with applicable regulations, customer requirements, and IQVIA SOPs.
  • Evaluate audit findings and prepare reports for operations staff, management, and customers.
  • Provide interpretation and consultation on regulations, guidelines, and policies to project teams.
  • Collaborate with the Quality Assurance team to develop and implement corrective action plans.
  • Review, approve, and track investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans for quality events arising from audits and quality issues.

Requirements:

  • Bachelor's Degree preferred.
  • 5 years of experience in pharmaceutical, technical, or related areas, with 3 years in Quality Assurance Audits.
  • Experienced in conducting CSR/DM/BIOS clinical trial audits.
  • Strong knowledge of word-processing, spreadsheet, and database applications.
  • Excellent problem-solving, risk analysis, and negotiation skills.