Analytical Development Project Coordinator
- Date de publication
In the frame of the growth of our business, we are looking for a:
**Analytical Development Project Coordinator**
* Execute and/or coordinate all the activities related to Analytical Method Development, Analytical Method Validation and Analytical Method Transfer.
* Execute and/or Coordinate routine Analytical Research activities of medical devices products.
* Trouble shooting related to Testing methods, Stability studies, Method Development and Method Validation. Design of additional experimentations, as necessary.
* Coordinate analytical activities carried out internally or by third party laboratories.
* Collect, verify, and interpret analytical results.
* Preparation and review of technical documents leading to dossier registrations.
* Preparation and review of Specifications, analysis procedures and Analytical development reports.
* Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.).
* Preparation of analytical technical documents for dossier and Regulatory submissions of projects.
* Assisting and resolving technical queries from notified bodies and health authorities.
* Assessment & coordination on regulatory deficiencies.
* Detect, report, and monitor any Deviation, OOS / OOT, Change Control or CAPA. Contribute or lead any related investigation to identify root cause.
* Any other specific functional activities defined on case-to-case basis.
* You have a solid educational background, (equivalent to a bachelor-s in science (Physic, Analytical Chemistry).
* Minimum of 5 years of experience in analytical chemistry in the pharmaceutical or Medical Device industry.
* Technical knowledge of analytical techniques (HPLC, UV, spectrophotometry, micro, etc)
* Knowledge of mass spectrometry, rheology or microbiology would be a plus
* Ability to work well with other departments
* Fluent in French with at least a B2 level in English