Clinical Trials Quality Assurance Auditor
hace 2 semanas
We are seeking a highly skilled Clinical Trials Quality Assurance Auditor to join our team. As a key member of our international team, you will be responsible for ensuring high-quality standards within our clinical trials and internal company processes.
Your responsibilities will include:
- Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits, and maintaining relevant communication with the auditee
- Communicating with project teams regarding QA study audits, including follow-up and resolution
- Assembling QA audits documentation
- Training PSI Operations staff in quality management topics
Please note that this role requires international travel for site audits.
Qualifications:
- 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
- Must have experience in planning, conducting, and reporting of QA audits
- Excellent knowledge of ICH GCP guidelines, EMA, and FDA regulations, and applicable local laws/regulations
- Team-oriented with superior communication and interpersonal skills, including a proactive attitude to tasks and projects
- Excellent time management skills
- Demonstrated ability to meet tight deadlines, multi-task, be flexible, and thrive in a fast-paced work environment
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to travel
At PSI CRO, we focus on our people and invest in their professional development and success. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
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