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