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 Description
- 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
Qualifications
- 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
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
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What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
