· Inspection of study plans to confirm compliance with GLP and company standards.
· Scheduling study and process inspections.
· Conducting study and process inspections by observing personnel in the laboratory to assure they are following relevant procedures and working in compliance with GLP.
· Inspection of facilities to assure the facility is fit for purpose and complies with the regulations.
· Inspection of study data and reports to confirm GLP compliance and assure that the study report reflects the raw data.
· Prepare and submit reports of inspection findings.
QUALIFICATIONS AND COMPETENCIES:
· 3 to 5 years QA experience
· Strong knowledge of GLP regulations
· Team work
· Interpersonal skills
· Problem Solving
· Fast paced
· Attention to detail
· Time Management
· Good command of the English language. Bilingual (French/English) an asset.