Alternant Assurance Qualité - Les Ulis, France - IPSEN

IPSEN

Entreprise vérifiée

Les Ulis, France

il y a 3 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Title:

Alternant Assurance Qualité H/F

Company:

Ipsen Innovation (SAS)

IpsenTraineeSquad

Ipsen is pleased to open a
12-month apprenticeship (alternance) in the Global R&D Quality Assurance team We are looking for a motivated
Pharmacy or scientific, engineering student to work in our R&D office in
Les Ulis, France.

Act as the Primary Contact to all Global Research and Development Quality (GRDQ) stakeholders which may have interactions with Service providers (SP) to ensure and maintain an adaptative and efficient quality oversight.

To be actively part of the maintenance of an efficient Quality System to oversee the Quality of the SPs under GRDQ scope to ensure compliance with Ipsen's quality standards, good working practices, local, national, regional, and international legal, ethical, and regulatory requirements.

Participate to maintaining and executing Service Provider quality oversight activities (Service Providers involved in Clinical, Non-Clinical, Regulatory and PV activities) to ensure quality is in line with the quality requirements and to ensure a continued state of inspection readiness.

Evaluate and monitor Service Providers regarding their compliance, their aptitude, and their competence to carry out the activities entrusted to them.

Ensure compliance with Ipsen's quality standards, good working practices and local, national, regional, and international legal, ethical and regulatory requirements of the Clinical and Non-Clinical Service Providers.

Promote a culture of continuous improvement.

Contribute to:

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Service Provider (SP) Quality Oversight from selection to closure:

Support the Quality Assurance Manager to prepare and to ensure the follow-up of the actions raised during the SP Quality Oversight Meetings (QOM).
Ensure Quality System management controlled
Be part of the evaluation of quality assessment of Service Provider during the selection,
Management of deviations and corrective and preventive actions linked to SPs,
SP Quality support for studies in liaison with the Clinical QA Representatives,
Support for audits and inspections preparation

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Continuous Improvement of the SP Quality Management Systems

Processes and Quality Documents

Analyse the actual processes governing the SPs to improve them and to propose alternatives to make the Quality Oversight more robust (e.g., Enhancement of the QD distribution process to SPs, Enhancement of the SP Master list process, etc.),

Creation of tools, presentations and plans to facilitate the implementation of procedures,
Contribute to the implementation of tools to increase oversight of service providers,

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Promote a culture of continuous improvement:

Preparation of presentations on this SP Quality Management which can be used during information sessions throughout the company but also to support Inspection,

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GRQ and GRQ Trainee Academy active team member:

Attend/Present at GRQ knowledge sharing meetings
Attend Ipsen internal events (presentations, external speakers, forums, webinars, celebrations)
Ensures adequate reporting of his/her activities and participates to various meetings depending on project assignments
Be an active member of the GRQ Trainee Academy (specific program designed to provide a framework for the GRQ interns and apprentices only): attending proposed trainings, prepare webcast, share experience, build network, site visits (if possible), get exposure to senior management. Provide feedback and participate in Trainee Academy further development and visibility.

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EHS Missions

Respect the regulations and EHS procedures in force.
Participate in the EHS performance of the site by reporting risks, malfunctions, or improvements.
Participate in mandatory EHS training.