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Quality Specialist, Change Control

Req #: 18000423_en
Location: Alliston, ON CA
Job Category: Quality
Date Posted: 2/27/2018 2:19:51 PM
Baxter International


This position is based at our manufacturing facility in Alliston, one hour north of Toronto
Oversees the CAPA process and Process/Product Change Control Systems      
·         Oversees the CAPA process ensuring that records are initiated and addressed in a timely fashion in accordance with Quality Management System (QMS) Requirements.
·         Supports review and approval of NCR and CAPA files.
·         Tracks all NCR and CAPA records to closure ensuring timeliness of all actions including correction/containment, investigation, corrective/preventive actions/effectiveness and closure.
·         Completes CAPA process metrics and trending in support of Corporate, Alliston Facility and Head Office Monthly Reporting
·         Oversees the Product Process Change Control Management (CCM) System ensuring timeliness of all actions including assessment, execution, implementation and closure.
·         Completes CCM metrics in support of Corporate, Alliston Facility Management Review and Head Office Monthly Reporting
·         Performs Instructor Led NCR and CAPA and CCM training for the Alliston Facility and acts as the facility system expert.
·         Leads the Alliston Change Control Review Board Meeting
·         Oversees the Supplier Notice of Change (SNC) program
Reviews applicable Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately


·         Education and training: University Degree, Bachelor of Science is required. Lean Green Belt designation is preferred
·         Minimum of 2-3 years of experience in a pharmaceutical environment. Over 5 years of experience is preferred.
·         Experience in a manufacturing and/or Quality background
·         Experience in a GMP environment and knowledge of ISO and Regulatory standards
·         Knowledge of Corporate Quality requirements is an asset
·         Strong understanding of Health Canada GMP and Medical Device Regulations.
·         Thorough knowledge of applicable procedures, specifications, regulations and standards.
·         Strong process and project management capabilities.
·         Highly effective written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
·         Ability to build strong relationships with internal and external customers.
·         Highly effective in balancing multiple priorities.
·         Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
·         Strong analytical and problem solving skills and critical thinking abilities.
·         Ability to support our transformation to a LEAN enterprise through the application of LEAN tools
·         Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
·         Proficiency in Trackwise System is an asset
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