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Clinical Audit Specialist
2 tygodni temu
We are seeking a highly skilled Clinical Audit Specialist 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, compliance status, and policies to project teams.
- Support the development and implementation of 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.
- Maintain the electronic quality management system (eQMS) and provide support throughout the audit lifecycle.
- Lead and collaborate on QA initiatives and projects for quality improvements.
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.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Excellent problem-solving, risk analysis, and negotiation skills.
- Ability to work independently and manage multiple projects.
