Reagent Operations manage the complete reagent manufacturing supply chain process, from raw material procurement, planning, manufacturing, product approval, warehousing and logistic services delivering finished goods to intermediate and end customers worldwide. Internally, Quality Assurance and Regulatory Affairs provide direction to ensure the company, the employees, and the company’s products, are compliant with the appropriate standards and regulations. Externally, our Technical Services/Field Services team support our customers, distributors, partners and sales teams for any technical matter covering all reagent and automated equipment distributed by IDS.
Stéphanie’s Career with IDS – From Technical Control Technician to Regulatory Affairs
In July 1995 I entered HycelLisabio Company on a one year temporary contract as a Technical Control Technician; I was 23 years old. I was given a permanent contract to help with the workload of production control due to the implementation of procedures for the ISO 9002 certification that was being established at the Pouilly site. By 2002 I was attached to the Quality Assurance System service in order to manage the regulatory affairs, and particularly the CE marking issue.
I moved to R&D quality, verification and validation in 2004. My role was mainly to establish a quality assurance system policy in the R&D service and to implement risk analysis in the design process. This position also led me to train the R&D team on the quality assurance system processes.
I came back to the Quality Assurance System service in 2007, filling the position of Quality Technician and Regulatory Affairs Technician. This position covered 2 main functions – Quality and Regulatory Affairs dimensions. For Quality, I was principally responsible for audits, participation to the drafting, diffusion, and evolution of the documentation of the quality assurance system. For Regulatory Affairs, I was responsible for tracking records of CE marking for their notification and also for the FDA certification of the products.
In 2009 I moved up from the level of technician to assistant in the same position. Throughout the years, IDS have supported me in a variety of training programmes which have included Senior Auditor Training, ISO13485, Medical Devices Risk Management and FDA Preparation Controls.
Stéphanie, France, Operations, Regulatory Affairs