SAINT CYR SUR MER
Dear All,
I have a proven experience, more than 15 years, in Biotechnology & Medical Devices (Class III) field within manufacturing operations, Supply chain activities and Engineering as well as continuous improvement culture implementation.
I used to work with my teams (up to 100 people) in clean room environments strictly regulated to ensure that our product conformity is safeguarded.
In order to do this, Medical devices and Pharmaceuticals manufacturers need a well-structured quality management system (QMS).
Keys of the success to ensure a product conformity is to have a very good knowledge of ISO standard 13485:2016 to meet customers requirements and 21 CFR 820 for FDA-regulated products.
And another side, we must have well-trained people regarding Current Good Manufacturing Practices (cGMP).One of my objective is to establish specifications for our products and processes and review of validated processes when change or deviations occur during production.
I'm passionate about identifying issues and finding solutions that can be implemented in the assets and the processes through operational excellence and continuous improvement to make immediate and significant impacts on the business. I'm also interested in interactions and how people work together to achieve the best results.
I'm a "Green belt" certified involved with Six Sigma, lean or other quality improvement projects.
I am motivated by processes optimization and complexity reduction.
Open minded, energetic, committed & results-oriented professional with a solid performance track.
If you feel you would like to know more than what is compiled below, feel free to contact me !
Mes compétences :
Management opérationnel
Gestion de projet
Veille technologique
Lean supply chain
Recrutement
AMDEC/FMECA
Planification
Gestion des stocks
Gestion de la production
Amélioration continue
Management et gestion d’équipes
Amélioration continue (Lean)
Gestion de planning de production
Maitrise de flux logistique
BPF & BPD et gestion documentaire ISO
ISO 22000
Six Sigma Green Belt
