Quality Assurance Engineer
Context
The Institut de la Vision is the largest integrated research centre for vision diseases in Europe, bringing together fundamental, clinical and industrial research on a single site. Built on the site of the 15-20 hospital in Paris, the Institut de la Vision (Sorbonne University, Inserm, CNRS) has around twenty teams divided into 5 departments; the clinical component of the Institute is the CIC1423 Inserm/DHOS clinical investigation centre and the rare disease reference centre for hereditary retinal dystrophies. This research institute is one of Sorbonne University's flagship research centres, and represents the research part of the Institut Hospitalo- Universitaire FOReSIGHT. Some fifteen technology platforms are available to researchers and their academic and industrial partners.
The NeuroSensCol Biological Resource Centre (BRC) specialises in the collection, extraction, conservation and distribution of high-quality genomic DNA for research purposes. The biological resources of the NeuroSensCol BRC come from patients suffering from neurosensory diseases, mainly retinal diseases, as well as from control subjects (unaffected family members for monogenic diseases or control subjects examined for complex diseases).
The CRB NeuroSensCol is ISO 9001 and NFS96-900 certified.
The research team
The post will report directly to the Institut de la Vision management team: Mr Serge PICAUD, Director and Ms Dominique SANTIARD-BARON, Administrative Director.
Missions
Your main tasks will be to:
- Monitoring the CRB Quality Management System and implementing the standards migration to ISO20 387
- Pursue the quality assurance policy covering the production, storage and archiving of data from the research laboratories in order to guarantee the Protection of the Scientific and Technical Potential (PPST) of the Institut de la Vision Research Centre.
Activities for the Biological Resources Centre :
- Implementing the migration to ISO20 387.
- Managing change situations, with the implementation of planning and risk analysis (migration of the QMS to meet ISO EN 20387 or ISO 9001 requirements),
- Monitoring the QMS (recording indicators, organising and implementing internal and external quality audits and improvement actions, organising management reviews) and driving continuous improvement (organising audits, monitoring improvement actions and impact analysis) with a view to maintaining ISO9001:2015 certification on the 2 sites (Institut de la Vision and Pitié-Salpêtrière (Biological Resources Platform))
- Disseminate and promote the results (quarterly oral presentations, management review, reports),
- Keeping a regulatory watch (legislation and quality standards),
- Communicating and providing information on regulatory and legal conditions relating to health and safety (staff).
- Ensuring that health and safety rules are applied.
Activities for the Institut de la Vision Research Centre
- Continuing to implement the key documents of an ISO 9001:2015-compliant quality management system for the platforms and research teams (protocols).
- Participating in the organisation of the Institute's security, flow management and information protection (risk analysis, mapping, procedures).
- Continuing to apply health and safety rules (control of professional risks, monitoring of equipment), and regulatory monitoring.
- Propose methods for archiving and backing up documents.
The allocation of activities between the CRB and the IDV will be decided by management in order of priority.
Skills required
Skills:
- Quality methods, tools, standards and procedures (in-depth knowledge)
- Written and oral presentation techniques (general knowledge)
- Foreign language: English B2 (Common European Framework of Reference for Languages)
Operational skills :
- Apply quality assurance procedures
- Managing a project
- Lead a meeting
- Monitor QA regulations
People skills :
- Team spirit
- Ability to organise according to priorities
- Analytical reasoning skills
- Critical thinking skills
Education and experience
- Master 2 in Quality Management
- Bachelor's degree in Biology is desirable or a background in life sciences.
- Knowledge of ISO20 387 would be an advantage.
- Proven professional experience in the field
How to apply
To apply for this vacancy, please complete this form and attach your cover letter and curriculum vitae in .pdf format. We will get back to you as soon as possible.