Coordinator, Equipment And Facility Qualification
Richmond Hill, Ontario, Canada
- Responsible for planning and authoring (IQOQs) and maintaining qualification activities for production equipment, facilities, and utilities (including Periodic Review) in accordance with the regulatory guidelines and.
- Identified maintenance and calibration requirements for critical items and documented these requirements in protocols to make sure items were established and verified.
- Developed user-friendly tools and guidelines to achieve a consistent approach to Qualification. Supported and implemented plans to ensure all Qualification work performed within Apotex Inc. was compliant to regulatory.
- Collaborated with other departments to achieve department objectives and business needs.
- Performed periodic reviews for major manufacturing and packaging equipment
- Monitored and tracked progress of non-GMP changes through Engineering Change Management (ECM) program