QA MC Administrator - Apprenticeship F/M

Since 2002, Median Technologies has been expanding the boundaries of the identification, interpretation, analysis and reporting of imaging data in the medical world. Our core activity is to develop advanced imaging software solutions and platforms for clinical drug development in oncology, diagnostic support, and cancer patient care. Our software solutions improve the management of cancer patients by helping to better identify pathologies, develop and select patient-specific therapies (precision medicine).

The company employs a highly-qualified team and leverages its scientific, technical, medical, and regulatory expertise to develop innovative medical imaging analysis software based on Artificial Intelligence, cloud computing and big data. We are driven by our core values that are essential to us. These values define who we are, what we do, the way we do it, and what we, as Median, aspire to:
• Leading innovation with purpose
• Committing to quality in all we do
• Supporting our customers in achieving their goals
• Always remembering to put the patient first

Today, we are a team of more than 220 people spread worldwide in the US, Europe and China. Our company is growing in a fulfilling international and multicultural environment.

We are looking for an Quality Assurance Administrator F/M in apprenticeship contract.

The Quality Assurance Software Process Owner is responsible to ensure that all the Computerized Systems used to perform the Quality Management Activities are effective, compliant to the applicable regulation and Median Standards. He is the first point of contact of all the Quality Assurance system users for any issue observed or change assessment. He is also in charge of the consistency and the harmonization of all the activities performed within those tools. Finally he is also highly involved in the monitoring and tracking of KPIs to demonstrate the efficiency of the quality assurance processes.

Main responsibilities 

• Process Owner of Electronic Document Management System and Training Management System : Create, monitor and archive user accesses.
• Supervise GCP training (assignation, follow up and archival).
• Support Functional System Administrative duties within QMS activities, troubleshooting, etc.
• Work with process owners to ensure consistency in the creation, review and approval of QMS documents, such as standard operating procedures, policies, guidance, work instructions.
• Work with other member of the QA team to ensure consistency and effectiveness of all Quality assurance activities performed within the QA Computerized systems.
• Support iCRO project creation and access management.
• Monitor KPI metrics to measure the results and efficiency of the quality assurance processes (i.e., Documentation, Training).

Education :

Bachelor’s Degree (Bac +3) or Master in progress in Quality Management (Quality Assurance & Quality Monitoring) 

Experience :1st experience (work-study contract/internship contract) in the field of Quality Management or a similar position in Pharmaceutical  field or clinical trials environment is a plus

Additional requirements:

• Knowledge of 21 CFR Part 11 is a plus
• Knowledge of GCP and ISO 13485 is a plus
• Knowledge of requirements for the use of computerized systems within medical environment or pharmaceutical environment mandatory
• Knowledge of Master Control’s or other EDMS tool is a plus
• Ability to work in an international environment
• English oral and proven written communication skills
• Hands-on profile, very autonomous
• Adaptability, open-mindedness and rigor