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Clinical Trials Quality Assurance Specialist
hace 2 meses
At PSI Cro, we are seeking a highly skilled Quality Assurance Auditor to join our international team. As a Quality Assurance Auditor, you will play a critical role in ensuring the high quality of our clinical trials and internal company processes.
Key Responsibilities:- Prepare, conduct, and report on QA study audits, internal systems, and location audits, as well as vendor qualification audits.
- Communicate effectively with project teams regarding QA study audits, including follow-up and resolution.
- Train PSI Operations staff in quality management topics.
- MD, PharmD, or degree in life sciences is a plus.
- A minimum of 3 years' experience in quality management or quality assurance in a clinical study environment.
- Excellent knowledge of ICH GCP guidelines, EMA, and FDA regulations, as well as applicable local laws and regulations.
- Team-oriented with superior communication and interpersonal skills, including a proactive attitude to tasks and projects.
- Demonstrated ability to meet tight deadlines, multi-task, and thrive in a fast-paced work environment.
- Full working proficiency in English.
- Proficiency in MS Office applications.
- Ability to travel.
This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this role.
