Computer System Validation Associate

PMRI is currently hiring: Computer System Validation Associate Head Office (full-time) Position Summary: Responsible for the PMRI CSV as well as FDA 21 CFR Part 11 initiatives   Duties and Responsibilities: Validate new and existing computerized systems for compliance with company SOPs, CSV program, and related regulatory requirements Create and maintain all corresponding validation documentation (i.e. master validation plan, CSV assessments, validation plan, IQ, OQ, PQ, CSV reports) Evaluate and maintain change controls Establish revalidation intervals and perform revalidation procedures Implement and maintain compliance with FDA 21 CFR Part 11   Qualifications: Post secondary education in a related discipline 2-3 years experience in a CSV role, with sound knowledge of regulatory (FDA, Health Canada, EU) validation requirements/procedures Working experience with FDA 21 CFR Part 11 Excellent interpersonal and organizational skills Must work effectively both independently and as a team member   Apply to:        jobs@pharmamedica.com with Job id #131006 indicated in the subject line   Scarborough Ajax Pickering human healthy adult health clinical trials phase 1 phase 2 phase 3 phase 4 I II III IV drug drugs generic prescription paid volunteer CRO

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