Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job DescriptionInteraction with project teams with regard to quality assurance (QA) study audits scheduling and preparationInteraction with company divisions with regard to internal systems audits scheduling and preparationInteraction with company offices with regard to internal locations audits scheduling and preparationLiaising with project teams with regard to maintenance of external systems/study audits tracking logLiaising with CAPA Investigation teams with regard to corrective/preventive actions implementation, tracking, and follow upInteraction with country Heads with regard to development/update of country level organizational chartsInteraction with PSI Systems Development personnel with regard to maintenance and management of the Release of PSI QSDs to external parties PRIMA applicationAdministrative support to PSI Quality Management (QM) staffAssistance to PSI QA auditors with quality assurance study audits scheduling and preparation Assistance to PSI QA auditors with vendor qualification audits scheduling and preparationAssistance to PSI QA auditors with internal systems and location audits scheduling and preparationAssistance to external Audit Host with the client/third party audits of PSI scheduling, planning, and hostingMaintenance of PSI internal and external audits tracking log, contracted audits tracking log, vendor qualification audits tracking log and of the CAPA tracking logMaintenance of PSI Quality FileMaintenance of the PSI organizational charts, including on the Group and country levelsAssembling of internal systems/locations/study audits documentationAssembling of contracted audits documentation, vendor qualification audits documentation, and external audits of PSI documentationMaintenance of PSI QSDs IntranetDevelopment and processing of Quality Management Records documenting QSD lifecycleAssistance to project teams, divisions, and offices with regard to the management of client/third party requests for QSD release through the PRIMA applicationManagement of the Quality Management Records related to release of PSI QSDs to external parties

QualificationsCollege or university degreeClinical research industry experience is a plusExperience working in a GxP setting a plusAdvanced proficiency in MS Office (Word, Excel, Power Point, Outlook)Strong oral and written communication skillsAbility to handle basic office equipmentGood formatting and proofreading skills

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.