Consultant QSM

Cyclad est une entreprise spécialisée dans le recrutement de profils qualifiés dans le domaine de l’informatique. Nous sommes présents en France, en Pologne et au Maroc. Nous misons sur la transparence et la proximité avec les experts qui nous rejoignent.

R&D & Medical activities are splitted in three main perimeters according to the development phase of the medicinal products:
• Research: this perimeter includes target identification and drug discovery activities. The QS includes the processes by which scientific data are collected, generated, and used.
• Non-Clinical Development: this perimeter includes notably nonclinical pharmacokinetic and toxicology activities. The QS is implemented following the relevant guidelines for facilities, systems, and procedures (Good Laboratory Practice (GLP)), if applicable.
• Clinical Development & Medical including post marketing clinical trials and life cycle management: all staff working on interventional clinical studies must follow current Good Clinical Practice (GCP), and where appropriate GLP, Good Manufacturing Practice and Good Pharmacovigilance Practices (GVP).

Management of a Quality Management System covering the following activities:
• Development of the annual quality plan with relevant stakeholders and monitoring of its implementation.
• Management of quality documents (SOPs/OPMs): review, creation, archiving, and workflow management within the eDMS.
• Review of procedures before validation to ensure consistency with the QMS and adherence to the format.
• Supporting business teams in drafting procedures.
• Developing training materials.
• Monitoring deviations and CAPAs.
• Managing changes.
• Preparing WRA quality reviews, with support from other QA components.
• Support implementation of the Corporate Quality Assurance.

The candidate should present the following profile:
• At least 5 to 10 years’ experience in the pharmaceutical industry with knowledge in quality management (GxP).
• Ideally previous experience in managing quality for regulatory affairs or pharmacovigilance perimeter.
• Excellent written and oral communication (French & English).
• Solutions oriented.
• Ability to work in a transversal manner, sense of contact.
• Proactive to predict issues and solve problems.
• Rigour.
|Langue : Français et Anglais | Lieu : Saclay"
Renouvellement possible