Quality System Officer
il y a 3 jours
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
**What we offer**:
The QMS Division within R&D Quality Assurance is in charge of implementing and maintaining the Quality System for the following activities:
- Coordination of R&D quality documents creation, update and distribution, in collaboration with personnel involved in R&D activities,
- Quality training ensuring that all R&D staff is appropriately trained on Standard Operating Procedures (SOPs) / Operating Manuals (OPMs) and applicable regulations,
- Definition and follow-up of the quality risk prevention strategy for projects,
- Edition of periodic metrics (quality indicators) and their analysis.
- To remain informed of any implementation or changes in international and/or national regulations/guidelines related to his/her activities within R&D GxP and to propose any appropriate action (e.g. change in QDs, process).
- To provide adequate support and advice to the concerned staff by ensuring the implementation of the quality policy and quality documents.
- To lead as QD Owner or to participate as QA Representative in the creation, update of QDs supporting the Process and QD Owners.
- To provide advice and support to R&D staff in the implementation of their training process.
- To create/update Quality training material (GCP, quality guidelines and regulation) and to participate in the training of R&D staff.
- To contribute to the Quality Risk Prevention (definition, follow-up and maintenance) for projects for which (s)he is responsible, with the other R&D QA Divisions and concerned structures.
- To follow the implementation of the Corrective Actions & Preventive Actions (CAPA), if any, for projects for which (s)he is responsible.
- To participate in regulatory inspections in supporting roles. To assist with the preparation, execution, preparation of responses to health authorities and follow-up
**Minimum Requirements**:
- At least 3 years’ experience in the pharmaceutical industry with knowledge in quality management, compliance (GxP, data privacy).
- Experience in laboratory environment and GLP would be appreciated.
- Solutions oriented.
- Excellent written and oral communication.
- Proactive to predict issues and solve problems.
- English
- Good knowledge and practice of Pack Office (PowerPoint, Excel,)
**Summary**:
- Type of job:
Full-time
- Location:
Paris Area
- Capability:
Quality Assurance
**Contact**:
- **Clara Rousselet-Blanc**
Talent Manager
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