Analytical Development Project Coordinator

Main responsibilities

• 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
• Ensure appropriate use and maintenance of the Teoxane Safety database in compliance with international regulatory authorities
• Review of annual reports for the specific safety section

Education and Qualifications

• 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