Psi CRO Ag
Quality Assurance Auditor (GCP)
Psi CRO Ag, Baltimore, Maryland, United States,
Clinical Trials Quality Assurance Auditor
Full-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.In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover.At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.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 maintaining relevant communication with the auditee.Communicating with project teams regarding QA study audits, including follow-up and resolution.Training PSI Operations staff in quality management topics.Please note, this role requires international travel for site audits.Minimum 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.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.Make 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. 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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Full-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.In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover.At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.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 maintaining relevant communication with the auditee.Communicating with project teams regarding QA study audits, including follow-up and resolution.Training PSI Operations staff in quality management topics.Please note, this role requires international travel for site audits.Minimum 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.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.Make 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. 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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