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Qa Coordinator

5+ years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Coordinator

Location: Warsaw, Poland
Job ID: R1492044
Job Type: Full-time
Work Mode: Hybrid
Additional Locations: Available


Company Overview

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence, connecting science, data, and technology to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes worldwide.

Learn more about IQVIA Careers


Job Overview

Support the auditing system lifecycle programs and processes across all Global QA business units, ensuring data integrity, regulatory compliance, and timely completion of audit-related activities.


Key Responsibilities

  • Maintain QA database(s) to ensure audits from plans/notifications are entered and updated.

  • Track and follow up on audits throughout the full audit lifecycle, including:

    • Identification and entry of missing information.

    • Confirmation of performed audits.

    • Entry of audit findings from Sponsor/Regulatory reports.

    • Follow-up on reports, CAPAs, and overdue critical/major findings.

    • Issuance and distribution of certificates and audit documentation.

  • Provide support and guidance to staff on complex queries regarding EDA usage.

  • Participate in systems validation processes (e.g., User Acceptance Testing).

  • Review and track documentation related to Global QA auditing lifecycle, including internal, external, contracted, and regulatory audits.

  • Maintain QA filing systems, both electronic and physical, for audit documentation and correspondence.

  • Produce reports, tables, and graphs from QA databases to highlight overdue information, trends, and compliance metrics.

  • Use metrics to optimize performance, productivity, and effectiveness of QA processes.

  • Develop and provide training on QA database processes for new or enhanced systems.

  • Keep updated on regulatory knowledge, trends, and developments, complying with SOPs and timelines.

  • Follow up and close audit/inspection CAPAs in the eQMS, including reviewing, approving, and performing effectiveness checks.

  • Categorize audit/inspection findings within the eQMS.


Qualifications

  • Education: High School Diploma or equivalent preferred.

  • Experience: 5+ years of relevant experience; equivalent combination of education, training, and experience considered.

  • Technical Skills:

    • Proficient in Microsoft Office (Word, Excel).

    • Proficient in electronic data management software.

    • Ability to review, approve, and publish electronic records.

  • Professional Skills:

    • Excellent written and verbal English communication skills.

    • Positive interaction, attention to detail, organizational skills.

    • Ability to handle multiple tasks and complete assignments with some supervision.

    • Problem-solving skills.

    • Ability to establish and maintain effective working relationships with coworkers, managers, and customers.

  • Regulatory Knowledge:

    • Awareness of basic GxP requirements.

    • Ability to learn scientific, medical, and regulatory terminology to understand QA data and generate metrics.

  • May participate in audit conduct.


Application

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