プロフィール詳細

プロジェクトを作成

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Dr. Imen S.に依頼

France

CQI Practionner, IRCA Lead Auditor xxxxxxxxxxx

プロフィール概要

monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards. Quality Management Representative | ISO 13485 | MDR/IVDR | MDSAP | GMP | FDA | Internal & Supplier Audits | Sterilization (EtO, Gamma, Plasma, Steam) | Cleanroom & Contamination Control |

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ ISO 13485
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance

サービス

• Consulting

Consulting Healthcare Consulting, Regulatory Consulting

職務経験

Quality manager

Novatech

1月 2022 - 現在

QA/QC Manager

Elitech Microbio

5月 2019 - 12月 2021

Scientific Consultant

Faculty of Pharmacy, University of Rennes

10月 2017 - 12月 2017

Lecturer and researcher in pharmaceutical microbiology

Faculty of Pharmacy, University of Rennes

9月 2015 - 12月 2017

学歴

Training in Quality, Safety and Environmental Management

CESI Engineering School

10月 2018 - 2月 2019

University Diploma in Antibiology and infectious diseases

Faculty of Medicine of Timone, University of Aix-Marseille.

9月 2014 - 6月 2015

Phd in Microbiology

Aix marseille university

1月 2010 - 5月 2014

認定資格

• IRCA CQI Lead auditor Training program on Medical devices xxxxxxxxxxx

  TUV SUDA

  2月 2026 - 現在