Quality Assurance - Validation Compliance Associate -BIOVAIL-CANADA-Steinbach, Manitoba
Review and approve facility protocols and reports associated with validation activities for cleaning, computer, methods and process validations including installation, operation and performance qualification for equipment, facilities and utilities.
Prepare, update and approve validation master plans (VMP), Site Reference Files, Quality Agreements, Annual Production Quality Reviews Summaries and Compliance Plans for the facility.
Participate in self-inspection and vendor audit programs to support validation review as scheduled.
Perform gap analysis of site procedures in relation to Global Policies and recommend required revisions.