Quality Assurance Auditor
hace 11 horas
Job Description
We are seeking a highly skilled Quality Assurance Auditor to join our team at PSI. As a Quality Assurance Auditor, you will play a critical role in ensuring the high quality standards of our clinical trials and internal company processes.
Your Responsibilities
- Conduct and report on QA study audits, internal systems and location audits, vendor qualification audits, and maintain relevant communication with the auditee.
- Communicate with project teams regarding QA study audits, including follow-up and resolution.
- Assemble QA audits documentation.
- Train PSI Operations staff in quality management topics.
Requirements
- 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.
Additional Information
At PSI, we value our employees 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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