- Interaction with project teams with regard to quality assurance (QA) study audits scheduling and preparation
- Interaction with company divisions with regard to internal systems audits scheduling and preparation
- Interaction with company offices with regard to internal locations audits scheduling and preparation
- Liaising with project teams with regard to maintenance of external systems/study audits tracking log
- Liaising with CAPA Investigation teams with regard to corrective/preventive actions implementation, tracking, and follow up
- Interaction with country Heads with regard to development/update of country level organizational charts
- Interaction with PSI Systems Development personnel with regard to maintenance and management of the Release of PSI QSDs to external parties PRIMA application
- Administrative support to PSI Quality Management (QM) staff
- Assistance to PSI QA auditors with quality assurance study audits scheduling and preparation
- Assistance to PSI QA auditors with vendor qualification audits scheduling and preparation
- Assistance to PSI QA auditors with internal systems and location audits scheduling and preparation
- Assistance to external Audit Host with the client/third party audits of PSI scheduling, planning, and hosting
- Maintenance of PSI internal and external audits tracking log, contracted audits tracking log, vendor qualification audits tracking log and of the CAPA tracking log
- Maintenance of PSI Quality File
- Maintenance of the PSI organizational charts, including on the Group and country levels
- Assembling of internal systems/locations/study audits documentation
- Assembling of contracted audits documentation, vendor qualification audits documentation, and external audits of PSI documentation
- Maintenance of PSI QSDs Intranet
- Development and processing of Quality Management Records documenting QSD lifecycle
- Assistance to project teams, divisions, and offices with regard to the management of client/third party requests for QSD release through the PRIMA application
- Management of the Quality Management Records related to release of PSI QSDs to external parties
- College or university degree
- Clinical research industry experience is a plus
- Experience working in a GxP setting a plus
- Advanced proficiency in MS Office (Word, Excel, Power Point, Outlook)
- Strong oral and written communication skills
- Ability to handle basic office equipment
- Good formatting and proofreading skills
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
