Profile Details

Create Project

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USD 50 /hr

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Hire Dr. Imen S.

France

USD 50 /hr

Quality mangement/Audit

Profile Summary

monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards. ISO 13485, ISO, 9001, MDSAP, FDA, internal audit, MDR, IVDR,. Quality control management: release and block batches Implementation of control tests

Subject Matter Expertise

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

Services

• Consulting

Consulting Digital Strategy Consulting, Regulatory Consulting

Work Experience

Quality manager

Novatech

January 2022 - Present

QA/QC Manager

Elitech Microbio

May 2019 - December 2021

Scientific Consultant

Faculty of Pharmacy, University of Rennes

October 2017 - December 2017

Lecturer and researcher in pharmaceutical microbiology

Faculty of Pharmacy, University of Rennes

September 2015 - December 2017

Education

Training in Quality, Safety and Environmental Management

CESI Engineering School

October 2018 - February 2019

University Diploma in Antibiology and infectious diseases

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

September 2014 - June 2015

Phd in Microbiology

Aix marseille university

January 2010 - May 2014

Certifications

• Certification details not provided.