The Quality Assurance Investigator will oversee investigations related to quality systems. They will follow up and communicate introductions and modifications to regulatory and pharmacopoeia guides.
Responsabilités:
- Investigation processing and report writing (DEV)
- Review and approval of laboratory investigations (LIR)
- Customer complaints program
- Review of new projects from a regulatory point of view
- Regulatory monitoring and Pharmacopoeia review
- Follow-up on registration with the FDA
- Drafting and review of Standard Operating Procedures (SOP)
Compétences et expérience requises:
- Bachelor’s degree in sciences (Chemistry, Biochemistry), or a discipline related
- Minimum of five (5) years of experience in quality assurance or quality control in the pharmaceutical industry
- Good Knowledge of Canadian Good Manufacturing Practices (GMP) (Health Canada) and American (FDA)
- Good technical writing
- The ability to work in a team and good communication skills
- Bilingual essential (French et English)