Clinical Trials Quality Assurance AuditorFull-timePSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.
You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.
Your responsibilities will include: Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditeeCommunicating with project teams with regard to QA study audits, including follow-up and resolutionTraining PSI Operations staff in quality management topicsPlease note, this role requires international travel for site audits. Minimum Requirements: MD, PharmD or degree in life sciences is a plusA minimum of 3 years' experience in quality management or quality assurance in clinical study environmentMust have experience in planning, conducting and reporting of QA auditsExcellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulationsTeam oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projectsDemonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environmentFull working proficiency in EnglishProficiency in MS Office applicationsAbility to travelMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
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