Lead Deviation Writer

Senior/Team Leader Deviation Writer
Toronto, ON

Management of a team of deviation coordinators working for a vaccine production department and for the quality control department responsible for in vivo, biochemical and physicochemical tests on vaccines during production and release
– Identify underlying causes and root case of deviations via interviews, GEMBA, 5Whys, ishikawa, Pareto or Process Mapping
-Determine potential consequences
-Create a plan to implement CAPAS
– Technical support for drafting deviations
– Review of deviations
– Training/coaching/support for deviation coordinators

Qualifications

Experience in Quality Assurance, QMS, supply chain, team and project management, RCA, CAPAs, QMS SAP

Fields of expertise :
Pharmaceutical industry
QA Operations & Systems
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